75 results on '"Gromski MA"'
Search Results
2. Development of a pancreatic tumor animal model and evaluation of NOTES® tumor enucleation
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Gromski, MA, Lee, SH, Thakkar, SJ, Lim, RB, Janschek, J, Jones, SB, Jones, DB, Chuttani, R, and Matthes, K
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- 2024
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3. Continuous monitoring of hemodynamics during complex NOTES® procedures
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Gromski, MA, primary, Lee, SH, additional, Thakkar, SJ, additional, Lim, RB, additional, Janschek, J, additional, Jones, SB, additional, Jones, DB, additional, Chuttani, R, additional, and Matthes, K, additional
- Published
- 2010
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4. Development of a pancreatic tumor animal model and evaluation of NOTES® tumor enucleation
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Gromski, MA, primary, Lee, SH, additional, Thakkar, SJ, additional, Lim, RB, additional, Janschek, J, additional, Jones, SB, additional, Jones, DB, additional, Chuttani, R, additional, and Matthes, K, additional
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- 2010
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5. Trainees' adenoma detection rate is higher if ≥ 10 minutes is spent on withdrawal during colonoscopy.
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Gromski MA, Miller CA, Lee SH, Park ES, Lee TH, Park SH, Chung IK, Kim SJ, Hwangbo Y, Gromski, Mark A, Miller, Christopher A, Lee, Suck-Ho, Park, Eun Seo, Lee, Tae Hoon, Park, Sang-Heum, Chung, Il-Kwun, Kim, Sun-Joo, and Hwangbo, Young
- Abstract
Background: It has been demonstrated that prolonged colonoscopic withdrawal times (WT; >6 min) are beneficial for the adenoma detection rate (ADR) for experienced endoscopists. There are little data, however, to guide the appropriate colonoscopic withdrawal times for trainees. The purpose of this study was to determine whether there is a relationship between WTs and ADR for first-year fellows training in colonoscopy.Methods: This is a prospective study of first-year gastroenterology fellows at a single academic teaching hospital who documented each colonoscopy with a self-report form over the course of an academic year (March 2010 to February 2011). The internal policy for the trainees was to have at least a 6-min withdrawal time for each colonoscopy.Results: Four first-year fellows in gastroenterology at an academic medical center completed self-reports for 1,210 colonoscopies. Mean WT was 10.2 ± 3.4 min. The aggregate polyp detection rate was 33.2% and the aggregate ADR was 22.3%. For colonoscopies with WT < 10 min, ADR was 9.5%, and for colonoscopies with WT ≥ 10 min, ADR was 32.3% (p < 0.001). When the quality indicator of 25% goal ADR for males and 15% goal ADR for females is applied, this aggregate rate is achieved for both sexes for screening colonoscopies (n = 676) with WT ≥ 10 min.Conclusions: First-year trainees had a significantly higher ADR if their colonoscopic WT is ≥ 10 min. [ABSTRACT FROM AUTHOR]- Published
- 2012
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6. Opioid-free single-incision laparoscopic (SIL) cholecystectomy using bilateral TAP blocks.
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Matthes K, Gromski MA, Schneider BE, and Spiegel JE
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- 2012
7. Risk factors for biliary strictures and leaks after living-donor liver transplantation: a systematic review and meta-analysis.
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Hassouneh R, Beran A, Rosenheck M, Sosio J, Olchawa N, Kubal C, Ghabril M, and Gromski MA
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- Humans, Risk Factors, Constriction, Pathologic etiology, Biliary Tract Diseases etiology, Biliary Tract Diseases epidemiology, End Stage Liver Disease surgery, Liver Transplantation adverse effects, Liver Transplantation methods, Living Donors, Postoperative Complications epidemiology, Postoperative Complications etiology, Anastomotic Leak etiology, Anastomotic Leak epidemiology
- Abstract
Background: Liver transplantation is the only curative treatment of end-stage liver disease. Unfortunately, a significant number of patients on the organ waitlist die waiting for an organ. Living-donor liver transplantation (LDLT) is an approach that has been used to expand organ availability. Although LDLT has excellent outcomes, biliary complications remain a significant drawback. This meta-analysis aimed to precisely assess the predictors of biliary stricture and leak after LDLT., Methods: PubMed, Embase, and Web of Science databases were searched from inception to January 2024. Only studies that used a multivariate model to assess risk factors for post-LDLT biliary stricture or leak in adult participants were included. Studies reporting unadjusted risk factors were excluded. Pooled adjusted odds ratios (ORs) and pooled hazard ratios (HRs) with 95% CIs for risk factors reported in ≥2 studies were obtained within a random-effects model., Results: Overall, 22 studies with 9442 patients who underwent LDLT were included. The post-LDLT biliary stricture rate was 22%, whereas the post-LDLT biliary leak rate was 14%. In addition, 13 unique risk factors were analyzed. Postoperative bile leak (OR, 4.10 [95% CI, 2.88-5.83]; HR, 3.88 [95% CI, 2.15-6.99]) was the most significant predictor of biliary stricture after LDLT. Other significant predictors of biliary stricture after LDLT were right lobe graft (OR, 2.56; 95% CI, 1.23-5.32), multiple ducts for anastomosis (OR, 1.62; 95% CI, 1.08-2.43), ductoplasty (OR, 2.07; 95% CI, 1.36-3.13), ABO incompatibility (OR, 1.45; 95% CI, 1.16-1.81), and acute cellular rejection (OR, 4.10; 95% CI, 2.88-5.83). Donor bile duct size (HR, 0.82; 95% CI, 0.74-0.91; P = .001, I
2 = 0%) was found to be significantly associated with reduced risk of post-LDLT biliary stricture. Donor age, recipient age, recipient male sex, and duct-to-duct anastomosis were not associated with an increased risk of post-LDLT biliary strictures. Multiple ducts for anastomosis (OR, 1.86; 95% CI, 1.43-2.43) was a significant predictor of post-LDLT biliary leak. Recipient age, warm ischemia time, and duct-to-duct anastomosis were not associated with an increased risk of post-LDLT biliary leak., Conclusion: In this meta-analysis, 7 unique risk factors were shown to be predictive of post-LDLT biliary stricture, one of which was associated with both post-LDLT biliary stricture and leak. Donor bile duct size was found to be protective against post-LDLT biliary strictures. Identifying reliable predictors is crucial for recognizing high-risk patients. This approach can facilitate the implementation of preventive measures, surveillance protocols, and targeted interventions to reduce the incidence of biliary strictures after LDLT., Competing Interests: Declaration of competing interest M.A.G. is a consultant of Boston Scientific and Ambu and receives research support from Olympus and Cook Medical. The other authors declare no competing interests., (Copyright © 2024 Society for Surgery of the Alimentary Tract. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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8. Managing the Bariatric Surgery Patient: Presurgery and Postsurgery Considerations.
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Yadlapati S, Sánchez-Luna SA, Gromski MA, and Mulki R
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- Humans, Patient Selection, Postoperative Care methods, Obesity, Morbid surgery, Postoperative Complications prevention & control, Postoperative Complications etiology, Obesity surgery, Bariatric Surgery methods, Preoperative Care methods
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Obesity has extensive health repercussions, and bariatric surgery remains a viable solution to address this issue. This article focuses on the preoperative and postoperative management strategies required to achieve successful and durable outcomes in bariatric surgery patients. Preoperative assessment includes appropriate patient selection, psychosocial evaluation, nutritional analysis, and behavioral/medical counseling. Postoperative assessment includes immediate perioperative care, diet transition, nutritional needs management, and handling of complications associated with bariatric surgery., (Published by Elsevier Inc.)
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- 2024
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9. Assessment of the Learning Curve for a Single-Use Disposable Duodenoscope.
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Saleem N, Tong Y, Sherman S, and Gromski MA
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- Humans, Retrospective Studies, Male, Female, Middle Aged, Aged, Clinical Competence, Equipment Design, Duodenoscopes microbiology, Learning Curve, Disposable Equipment, Cholangiopancreatography, Endoscopic Retrograde instrumentation, Cholangiopancreatography, Endoscopic Retrograde methods
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Background and Aims: In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope., Methods: We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures., Results: Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation., Conclusion: Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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10. Updates on the Prevention and Management of Post-Polypectomy Bleeding in the Colon.
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Wehbe H, Gutta A, and Gromski MA
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- Humans, Colon, Risk Factors, Postoperative Hemorrhage, Colonic Polyps surgery, Colonoscopy adverse effects, Colonoscopy methods, Gastrointestinal Hemorrhage etiology
- Abstract
Post-polypectomy bleeding (PPB) remains a significant procedure-related complication, with multiple risk factors determining the risk including patient demographics, polyp characteristics, endoscopist expertise, and techniques of polypectomy. Immediate PPB is usually treated promptly, but management of delayed PPB can be challenging. Cold snare polypectomy is the optimal technique for small sessile polyps with hot snare polypectomy for pedunculated and large sessile polyps. Topical hemostatic powders and gels are being investigated for the prevention and management of PPB. Further studies are needed to compare these topical agents with conventional therapy., Competing Interests: Conflict of interest M.A. Gromski: Consultant (Boston Scientific). None of the other contributing authors have any conflict of interest, including specific financial interests or relationships and affiliations relevant to the subject matter or materials discussed in this article., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2024
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11. Primary Sclerosing Cholangitis Limited to Intrahepatic Bile Ducts Has Distinctly Better Prognosis.
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Are VS, Gromski MA, Akisik F, Vilar-Gomez E, Lammert C, Ghabril M, Vuppalanchi R, and Chalasani N
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- Humans, Bile Ducts, Intrahepatic, Prognosis, Bile Ducts, Cholangitis, Sclerosing therapy, Liver Transplantation, Bile Duct Neoplasms, Cholangiocarcinoma
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Background: There are two sub-phenotypes of large-duct primary sclerosing cholangitis (PSC): isolated intrahepatic PSC (IIPSC) and extrahepatic disease with or without intrahepatic (extra/intrahepatic)., Aims: This study examined the differences in outcomes in patients with IIPSC compared to extra/intrahepatic and small-duct PSC., Methods: Patients with PSC treated at our institution from 1998 to 2019 were investigated. Biochemistries, clinical events, and survival were assessed by chart review and National Death Index. Cox-proportional hazards were used to determine the risk of clinical outcomes based on biliary tract involvement., Results: Our cohort comprised 442 patients with large-duct PSC (57 had IIPSC, 385 had extra/intrahepatic PSC) and 23 with small-duct PSC. Median follow-up in the IIPSC group was not significantly different from the extra/intrahepatic group [7 vs. 6 years, P = 0.06]. Except for lower age (mean 37.9 vs. 43.0 years, P = 0.045), the IIPSC group was not different from the extra/intrahepatic. The IIPSC group had longer transplant-free survival (log-rank P = 0.001) with a significantly lower risk for liver transplantation (12% vs. 34%, P < 0.001). The IIPSC group had a lower risk of death or transplantation than the extra/intrahepatic PSC group [HR: 0.34, 95% CI: 0.17-0.67, P < 0.001]. No bile duct or gallbladder cancers developed in patients with IIPSC, compared to 24 in the extra/intrahepatic group. The clinical characteristics and outcomes of IIPSC were similar to 23 individuals with small-duct PSC., Conclusions: Patients with IIPSC have a favorable prognosis similar to small-duct PSC. These data are important for counseling patients and designing therapeutic trials for PSC., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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12. Endoscopic sleeve gastroplasty: stomach location and task classification for evaluation using artificial intelligence.
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Dials J, Demirel D, Sanchez-Arias R, Halic T, De S, and Gromski MA
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- Animals, Swine, Obesity surgery, Artificial Intelligence, Weight Loss, Treatment Outcome, Stomach diagnostic imaging, Stomach surgery, Gastroplasty methods
- Abstract
Purpose: We have previously developed grading metrics to objectively measure endoscopist performance in endoscopic sleeve gastroplasty (ESG). One of our primary goals is to automate the process of measuring performance. To achieve this goal, the repeated task being performed (grasping or suturing) and the location of the endoscopic suturing device in the stomach (Incisura, Anterior Wall, Greater Curvature, or Posterior Wall) need to be accurately recorded., Methods: For this study, we populated our dataset using screenshots and video clips from experts carrying out the ESG procedure on ex vivo porcine specimens. Data augmentation was used to enlarge our dataset, and synthetic minority oversampling (SMOTE) to balance it. We performed stomach localization for parts of the stomach and task classification using deep learning for images and computer vision for videos., Results: Classifying the stomach's location from the endoscope without SMOTE for images resulted in 89% and 84% testing and validation accuracy, respectively. For classifying the location of the stomach from the endoscope with SMOTE, the accuracies were 97% and 90% for images, while for videos, the accuracies were 99% and 98% for testing and validation, respectively. For task classification, the accuracies were 97% and 89% for images, while for videos, the accuracies were 100% for both testing and validation, respectively., Conclusion: We classified the four different stomach parts manipulated during the ESG procedure with 97% training accuracy and classified two repeated tasks with 99% training accuracy with images. We also classified the four parts of the stomach with a 99% training accuracy and two repeated tasks with a 100% training accuracy with video frames. This work will be essential in automating feedback mechanisms for learners in ESG., (© 2024. CARS.)
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- 2024
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13. Timing of ERCP after extracorporeal shock wave lithotripsy for large main pancreatic duct stones.
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Saleem N, Patel F, Watkins JL, McHenry L, Easler JJ, Fogel EL, Gromski MA, Lehman GA, Sherman S, Tong Y, and Bick BL
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- Humans, Cholangiopancreatography, Endoscopic Retrograde methods, Retrospective Studies, Treatment Outcome, Pancreatic Ducts, Calculi, Lithotripsy adverse effects, Lithotripsy methods, Pancreatic Diseases therapy, Pancreatic Diseases etiology
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Background and Aims: Extracorporeal shock wave lithotripsy (ESWL) is performed to fragment large main pancreatic duct (MPD) stones in symptomatic patients. Subsequent endoscopic retrograde cholangiopancreatography (ERCP) is often performed to clear the stone fragments. Edema of surrounding tissue after ESWL theoretically affects the ability to perform ERCP. However, the optimal timing of ERCP after ESWL is not clearly defined. The aim of this study is to determine the efficacy and safety of same-day ERCP after ESWL and to determine if the timing of ERCP after ESWL affects outcomes., Methods: This is a retrospective study of consecutive patients from January, 2013 to September, 2019 who received ESWL for MPD stones at our center. Included patients received subsequent same-day ERCP under the same general anesthesia session or later session ERCP (1-30 days after ESWL). Demographics, anatomical findings, history, and outcomes were collected. Success was defined as complete or near complete (> 80%) stone fragmentation with clearance., Results: 218 patients were treated with ESWL and subsequent ERCP. 133 (61.0%) received ERCP on the same day immediately after ESWL, while 85 (39.0%) returned for ERCP at a later day (median 3.0 days after ESWL). Baseline characteristics demonstrated patients who received same-day ERCP had a higher rate of pain at baseline (94.7% vs 87.1%, p = 0.045). Main outcomes demonstrated an overall successful MPD stone clearance rate of 90.4%, with similar rates between same-day ERCP and later session ERCP (91.7% vs 88.2%, p = 0.394). Additionally, successful cannulation at ERCP, adverse events, and post-procedure admission rates were similar., Conclusions: Delaying ERCP to allow peripancreatic tissue recovery after ESWL does not affect outcomes. Same-day ERCP after ESWL is safe and effective., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2023
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14. Skill-level classification and performance evaluation for endoscopic sleeve gastroplasty.
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Dials J, Demirel D, Sanchez-Arias R, Halic T, Kruger U, De S, and Gromski MA
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- Humans, Algorithms, Machine Learning, Random Forest, Support Vector Machine, Gastroplasty
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Background: We previously developed grading metrics for quantitative performance measurement for simulated endoscopic sleeve gastroplasty (ESG) to create a scalar reference to classify subjects into experts and novices. In this work, we used synthetic data generation and expanded our skill level analysis using machine learning techniques., Methods: We used the synthetic data generation algorithm SMOTE to expand and balance our dataset of seven actual simulated ESG procedures using synthetic data. We performed optimization to seek optimum metrics to classify experts and novices by identifying the most critical and distinctive sub-tasks. We used support vector machine (SVM), AdaBoost, K-nearest neighbors (KNN) Kernel Fisher discriminant analysis (KFDA), random forest, and decision tree classifiers to classify surgeons as experts or novices after grading. Furthermore, we used an optimization model to create weights for each task and separate the clusters by maximizing the distance between the expert and novice scores., Results: We split our dataset into a training set of 15 samples and a testing dataset of five samples. We put this dataset through six classifiers, SVM, KFDA, AdaBoost, KNN, random forest, and decision tree, resulting in 0.94, 0.94, 1.00, 1.00, 1.00, and 1.00 accuracy, respectively, for training and 1.00 accuracy for the testing results for SVM and AdaBoost. Our optimization model maximized the distance between the expert and novice groups from 2 to 53.72., Conclusion: This paper shows that feature reduction, in combination with classification algorithms such as SVM and KNN, can be used in tandem to classify endoscopists as experts or novices based on their results recorded using our grading metrics. Furthermore, this work introduces a non-linear constraint optimization to separate the two clusters and find the most important tasks using weights., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2023
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15. Utilization pattern of prophylactic measures for prevention of post-ERCP pancreatitis: a National Survey Study.
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Ashat M, Kandula S, Cote GA, Gromski MA, Fogel EL, Sherman S, Lehman GA, Watkins JL, Bick BL, and Easler JJ
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- Humans, Pancreatic Ducts, Catheterization, Indomethacin therapeutic use, Stents adverse effects, Risk Factors, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Cholangiopancreatography, Endoscopic Retrograde methods, Pancreatitis etiology, Pancreatitis prevention & control, Pancreatitis epidemiology
- Abstract
Background and Aims: Post-ERCP pancreatitis (PEP) is the most frequent adverse event of ERCP. Various prophylactic measures are endorsed by the American Society for Gastrointestinal Endoscopy and the European Society of Gastrointestinal Endoscopy to both lower the incidence of PEP and to decrease its severity. The extent to which these interventions are practiced throughout the United States is unclear. The aim of this study was to describe the utilization pattern of various PEP measures and determine factors that affect utilization of these measures., Methods: A 27-question electronic survey was distributed using a cloud-based program (Qualtrics). The questions assessed ERCP training, practice setting, experience, practice patterns, and perceptions for PEP prophylaxis interventions. Endoscopists with practices based in the United States listed in the American Society for Gastrointestinal Endoscopy member directory received a survey invitation via e-mail. The invitation outlined the study and contained a link with instructions to complete the voluntary survey if they had an active ERCP practice. Data were de-identified for the purposes of analysis., Results: Of survey respondents (N = 319), 46% reported therapeutic endoscopy fellowship training and 37% practiced in teaching programs. Annualized ERCP volume of >100 cases per year were reported by 47%, with pancreatic ERCP comprising ≤5% of procedure volume reported by the majority of respondents (61%). The majority of respondents used prophylactic pancreatic stent (PPS), and 54% reported frequent use during high-risk ERCP. The most common indications for PPS were difficult cannulation, to assist biliary access, and multiple pancreatic duct injections. Most respondents reported frequent use of indomethacin (89%). Of physicians who did not use PPS, use of indomethacin was the most common reason (80%). Variables associated with frequent use of PPS were ERCP fellowship training (P ≤ .001), practice at a teaching program (P ≤ .001), <10 years in practice (P = .005), higher procedure volume (P ≤ .001), and higher proportion of pancreatic cases (P ≤ .001)., Conclusions: Physicians with higher annual ERCP volume, who teach at hospital-based ERCP practices, and who regularly perform pancreatic ERCP are more likely to use PPS. Therapeutic ERCP fellowship training and recent entry into practice were also associated with PPS utilization. Indomethacin use seems to be more frequent than PPS. Our findings suggest that indomethacin is supplanting PPS as the preferred method of PEP prophylaxis., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2023
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16. Duodenal mucosal resurfacing for nonalcoholic fatty liver disease.
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Shamseddeen H, Vuppalanchi R, and Gromski MA
- Abstract
Content available: Author Interview and Audio Recording., Competing Interests: R.V. and M.A.G. have received research support from Fractyl. M.A.G. has received research support from Allurion Technologies, and consults for Boston Scientific., (© 2022 American Association for the Study of Liver Diseases.)
- Published
- 2022
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17. Microbiology of bile aspirates obtained at ERCP in patients with suspected acute cholangitis.
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Gromski MA, Gutta A, Lehman GA, Tong Y, Fogel EL, Watkins JL, Easler JJ, Bick BL, McHenry L, Beeler C, Relich RF, Schmitt BH, and Sherman S
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- Humans, Bile microbiology, Retrospective Studies, Anti-Bacterial Agents therapeutic use, Ciprofloxacin, Enterococcus, Cholangiopancreatography, Endoscopic Retrograde methods, Cholangitis drug therapy
- Abstract
Background: The cornerstone of treatment for acute cholangitis is source control with biliary drainage and early antibiotics. The primary aim of this study was to describe the microbiology of bile aspirate pathogens obtained at the time of endoscopic retrograde cholangiopancreatography (ERCP) in patients suspected of having acute cholangitis., Methods: In this single-center retrospective study, patients were included if a bile aspirate was collected at ERCP for suspicion of acute cholangitis, from 1 January 2010 to 31 December 2016., Results: There were 721 ERCP procedures for suspected acute cholangitis with bile culture results, with 662 positive bile cultures (91.8 %). Pathogens included: Enterococcus species (spp.) 448 (67.7 %); Klebsiella spp. 295 (44.6 %); Escherichia coli 269 (40.6 %); Pseudomonas spp. 52 (7.9 %); and anaerobes 64 (9.7 %). Susceptibility of Klebsiella pneumoniae and E.coli isolates to ciprofloxacin was 88 % and 64 %, respectively. Extended-spectrum beta-lactamases and carbapenem resistance were found in 7.9 % and 3.6 % of Enterobacteriaceae, respectively. There were 437 concurrent blood cultures, of which 174 were positive (39.8 % of cultures drawn). Prior biliary endoscopic sphincterotomy (ES) was evident in 459 ERCP cases (63.7 %), and was associated with increased frequency of Klebsiella spp., Pseudomonas aeruginosa , Enterobacter spp., and Enterococcus spp. Prior biliary ES significantly increased the probability of vancomycin-resistant Enterococcus (VRE)., Conclusions: The vast majority of bile cultures (91.8 %) were positive. The susceptibilities of E.coli and K.pneumoniae to ciprofloxacin are lower than historically noted. A notable portion of cultures contained pathogenic drug-resistant organisms. Prior biliary ES is associated with a higher frequency of certain organisms and higher frequency of VRE., Competing Interests: M.A. Gromski serves as a consultant for Boston Scientific. S. Sherman serves as a consultant for Boston Scientific, Cook Medical, and Olympus. G. Lehman serves as a consultant for Cook Endoscopy. J. Easler serves as a consultant for Boston Scientific. The remaining authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
- Published
- 2022
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18. Reply to Chaudhari et al.
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Gromski MA, Gutta A, and Sherman S
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Competing Interests: Mark Gromski is a consultant for Boston Scientific. Stuart Sherman is a consultant for Boston Scientific, Cook Medical, and Olympus. Aditya Gutta declares no conflict of interest.
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- 2022
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19. Hierarchical task analysis of endoscopic sleeve gastroplasty.
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Dials J, Demirel D, Halic T, De S, Ryason A, Kundumadam S, Al-Haddad M, and Gromski MA
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- Endoscopy methods, Humans, Reproducibility of Results, Treatment Outcome, Weight Loss, Gastroplasty methods
- Abstract
Background: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic weight loss procedure used to treat obesity. The long-term goal of this project is to develop a Virtual Bariatric Endoscopy (ViBE) simulator for training and assessment of the ESG procedure. The objectives of this current work are to: (a) perform a task analysis of ESG and (b) create metrics to be validated in the created simulator., Methods: We performed a hierarchical task analysis (HTA) by identifying the significant tasks of the ESG procedure. We created the HTA to show the breakdown and connection of the tasks of the procedure. Utilizing the HTA and input from ESG experts, performance metrics were derived for objective measurement of the ESG procedure. Three blinded video raters analyzed seven recorded ESG procedures according to the proposed performance metrics., Results: Based on the seven videos, there was a positive correlation between total task times and total performance scores (R = 0.886, P = 0.008). Endoscopists expert were found to be more skilled in reducing the area of the stomach compared to endoscopists novice (34.6% reduction versus 9.4% reduction, P = 0.01). The mean novice performance score was significantly lower than the mean expert performance score (34.7 vs. 23.8, P = 0.047). The inter-rater reliability test showed a perfect agreement among three raters for all tasks except for the suturing task. The suturing task had a significant agreement (Inter-rater Correlation = 0.84, Cronbach's alpha = 0.88). Suturing was determined to be a critical task that is positively correlated with the total score (R = 0.962, P = 0.0005)., Conclusion: The task analysis and metrics development are critical for the development of the ViBE simulator. This preliminary assessment demonstrates that the performance metrics provide an accurate assessment of the endoscopist's performance. Further validation testing and refinement of the performance metrics are anticipated., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2022
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20. Biliary Stricture After Necrotizing Pancreatitis: An Underappreciated Challenge.
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Maatman TK, Ceppa EP, Fogel EL, Easier JJ, Gromski MA, House MG, Nakeeb A, Schmidt CM, Sherman S, and Zyromski NJ
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- Cholangiopancreatography, Endoscopic Retrograde, Constriction, Pathologic etiology, Constriction, Pathologic surgery, Humans, Necrosis, Neoplasm Recurrence, Local, Treatment Outcome, Pancreatitis, Acute Necrotizing complications, Pancreatitis, Acute Necrotizing surgery, Thrombosis
- Abstract
Objective: Biliary stricture in necrotizing pancreatitis (NP) has not been systematically categorized; therefore, we sought to define the incidence and natural history of biliary stricture caused by NP., Summary of Background Data: Benign biliary stricture occurs secondary to bile duct injury, anastomotic narrowing, or chronic inflammation and fibrosis. The profound locoregional inflammatory response of NP creates challenging biliary strictures., Methods: NP patients treated between 2005 and 2019 were reviewed. Biliary stricture was identified on cholangiography as narrowing of the extrahepatic biliary tree to <75% of the diameter of the unaffected duct. Biliary stricture risk factors and outcomes were evaluated., Results: Among 743 NP patients, 64 died, 13 were lost to follow-up; therefore, a total of 666 patients were included in the final cohort. Biliary stricture developed in 108 (16%) patients. Mean follow up was 3.5 ± 3.3 years. Median time from NP onset to biliary stricture diagnosis was 4.2 months (interquartile range, 1.8 to 10.9). Presentation was commonly clinical or biochemical jaundice, n = 30 (28%) each. Risk factors for stricture development were splanchnic vein thrombosis and pancreatic head parenchymal necrosis. Median time to stricture resolution was 6.0 months after onset (2.8 to 9.8). A mean of 3.3 ± 2.3 procedures were performed. Surgical intervention was required in 22 (20%) patients. Endoscopic treatment failed in 17% (17/99) of patients and was not associated with stricture length. Operative treatment of biliary stricture was more likely in patients with infected necrosis or NP disease duration ≥6 months., Conclusion: Biliary stricture occurs frequently after NP and is associated with splanchnic vein thrombosis and pancreatic head necrosis. Surgical correction was performed in 20%., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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21. A comparative study between single-operator pancreatoscopy with intraductal lithotripsy and extracorporeal shock wave lithotripsy for the management of large main pancreatic duct stones.
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Bick BL, Patel F, Easler JJ, Tong Y, Watkins JL, McHenry L, Lehman G, Fogel EL, Gromski MA, and Sherman S
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- Cholangiopancreatography, Endoscopic Retrograde methods, Humans, Pancreatic Ducts, Retrospective Studies, Treatment Outcome, Calculi therapy, Lithotripsy methods, Pancreatic Diseases etiology, Pancreatic Diseases therapy
- Abstract
Background and Aims: Endoscopic management of large main pancreatic ductal (MPD) stones often require treatment with lithotripsy. Extracorporeal shock wave lithotripsy (ESWL) has been the mainstay therapy, and single-operator pancreatoscopy with intraductal (intracorporeal) lithotripsy (SOPIL) is an emerging technique. However, no comparative studies between these techniques exist. We therefore aimed to compare ESWL to SOPIL for the treatment of large MPD stones., Methods: This is a retrospective cohort study comparing patients who were treated with ESWL or SOPIL from September 2013 to September 2019 at a single tertiary center. Logistic regression was performed to identify factors associated with technical success and efficient stone clearance (≤ 2 procedures to clear stones)., Results: There were 240 patients who were treated with ESWL and 18 treated with SOPIL. The overall technical success rate of stone clearance was 224/258 (86.8%), which was similar between the ESWL and SOPIL groups (86.7% vs 88.9%, p = 1.000). A SOPIL approach required fewer total procedures (1.6 ± 0.6 vs 3.1 ± 1.5, p < 0.001) and less aggregate procedure time (101.6 ± 68.2 vs 191.8 ± 111.6 min, p = 0.001). Adverse event rates were similar between the groups (6.3% vs 5.6%, p = 1.000). The use of SOPIL was independently associated with greater efficiency compared to ESWL (OR 5.241 [1.348-20.369], p = 0.017). Stone size > 10 mm was associated with less efficient stone clearance (OR 0.484 [0.256-0.912], p = 0.025)., Conclusion: Both ESWL and SOPIL are safe and effective endoscopic adjunct modalities for treating large pancreatic duct stones. SOPIL is an emerging alternative to ESWL that is potentially more efficient for lithotripsy and MPD stone clearance., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2022
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22. Critical Illness Cholangiopathy in COVID-19 Long-haulers.
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Saleem N, Li BH, Vuppalanchi R, Gawrieh S, and Gromski MA
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- 2022
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23. Technological review: developments in innovative duodenoscopes.
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Gromski MA and Sherman S
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- Cholangiopancreatography, Endoscopic Retrograde, Disinfection, Humans, Duodenoscopes, Equipment Contamination
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- 2022
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24. Looks can be deceiving: the continued need for tissue in indeterminate biliary strictures.
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Gutta A and Gromski MA
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- Bile Ducts, Intrahepatic, Constriction, Pathologic etiology, Humans, Cholestasis etiology
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- 2021
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25. Racial differences in primary sclerosing cholangitis mortality is associated with community socioeconomic status.
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Are VS, Vilar-Gomez E, Gromski MA, Akisik F, Lammert C, Ghabril M, Chalasani N, Vuppalanchi R, and Nephew LD
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- Humans, Prospective Studies, Race Factors, Risk Factors, Social Class, White People, Cholangitis, Sclerosing
- Abstract
Background and Aims: Natural history and outcomes data in PSC are mostly derived from cohorts where Blacks have been underrepresented. It is unknown if there are differences in mortality between Blacks and Whites with PSC., Methods: PSC patients seen at our institution from June 1988 to Jan 2019 were identified by merging prospective ERCP hepatology-clinic databases and liver-transplant registry. Data on race, clinical events, and death was obtained through chart review. Data on community health were collected using indices from county health rankings. Cumulative incidence of death was calculated using liver transplant (LT) as a competing risk., Results: Of 449 patients, 404 were White and 45 were Black. The median-duration of follow-up was 7 years (IQR:3, 13). Black patients were younger at presentation than White patients (36.3 vs 42.5 years., P = .013). Disease severity as indicated by Mayo Risk Score categories (low 27% vs 31%, intermediate 54% vs 49% and high 19% vs 19%, P = .690), comorbidity burden and frequency of cirrhosis (42% vs 35%, P = .411) were similar between Blacks and Whites. Cumulative incidence of liver-related death, with LT as a competing risk was significantly higher in Blacks compared to Whites (sHR 1.80, 95%CI 1.25, 2.61, P = .002). There was a significant interaction between race and community socioeconomic factors that attenuated the racial difference in mortality (sHR 1.01, 95%CI 0.99, 1.04, P = .345)., Conclusions: Blacks with PSC present at a younger age with a similar disease severity as Whites but have higher liver related mortality that is mediated in part through community health., (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
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- 2021
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26. Outcomes in Endoscopic and Operative Transgastric Pancreatic Debridement.
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Maatman TK, McGuire SP, Flick KF, Madison MK, Al-Haddad MA, Bick BL, Ceppa EP, DeWitt JM, Easler JJ, Fogel EL, Gromski MA, House MG, Lehman GA, Nakeeb A, Schmidt CM, Sherman S, Watkins JL, and Zyromski NJ
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- Female, Humans, Indiana, Length of Stay statistics & numerical data, Male, Middle Aged, Pancreatitis, Acute Necrotizing mortality, Debridement methods, Laparoscopy methods, Laparotomy methods, Pancreatitis, Acute Necrotizing surgery
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Objectives: Select patients with anatomically favorable walled off pancreatic necrosis may be treated by endoscopic (Endo-TGD) or operative (OR-TGD) transgastric debridement (TGD). We compared our experience with these 2 approaches., Summary Background Data: Select necrotizing pancreatitis (NP) patients are suitable for TGD which may be accomplished endoscopically or surgically. Limited experience exists contrasting these techniques exists., Methods: Patients undergoing Endo-TGD and OR-TGD at a single, high-volume pancreatic center between 2008 and 2019 were identified from a prospective database. Patient characteristics, procedural details, and outcomes of these 2 groups were compared., Results: Among 498 NP patients undergoing necrosis intervention, 160 (32%) had TGD: 59 Endo-TGD and 101 OR-TGD. The groups were statistically similar in age, comorbidity, pancreatitis etiology, necrosis anatomy, pancreatitis severity, and timing of TGD from pancreatitis insult. OR-TGD required 1.1 ± 0.5 and Endo-TGD 3.0 ± 2.0 debridements/patient. Fewer hospital readmissions and repeat necrosis interventions, and shorter total inpatient length of stay were observed in OR-TGD patients. New-onset organ failure [Endo-TGD (13%); OR-TGD (13%); P = 1.0] was similar between groups. Hospital length of stay after TGD was significantly longer in patients undergoing Endo-TGD (13.8 ± 20.8 days) compared to OR-TGD (9.4 ± 6.1 days; P = 0.047). Mortality was 7% in Endo-TGD and 1% in OR-TGD (P = 0.04)., Conclusions: Operative and endoscopic transgastric debridement achieve necrosis resolution with different temporal and procedural profiles. Clear multidisciplinary communication is essential to determine appropriate approach to individual necrotizing pancreatitis patients., Competing Interests: The authors report no conflicts of interests., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2021
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27. Combined Versus Separate Sessions of Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for the Diagnosis and Management of Pancreatic Ductal Adenocarcinoma with Biliary Obstruction.
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Purnak T, El Hajj II, Sherman S, Fogel EL, McHenry L, Lehman G, Gromski MA, Al-Haddad M, DeWitt J, Watkins JL, and Easler JJ
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- Cholestasis therapy, Humans, Retrospective Studies, Adenocarcinoma complications, Cholangiopancreatography, Endoscopic Retrograde methods, Cholestasis etiology, Endosonography methods, Pancreatic Neoplasms complications
- Abstract
Background: A single-procedure session combining EUS and ERCP (EUS/ERCP) for tissue diagnosis and biliary decompression for pancreatic duct adenocarcinoma (PDAC) is technically feasible. While EUS/ERCP may offer expedience and convenience over an approach of separate procedures sessions, the technical success and risk for complications of a combined approach is unclear., Aims: Compare the effectiveness and safety of EUS/ERCP versus separate session approaches for PDAC., Methods: Study patients (2010-2015) were identified within our ERCP database. Patients were analyzed in three groups based on approach: Group A: Single-session EUS-FNA and ERCP (EUS/ERCP), Group B: EUS-FNA followed by separate, subsequent ERCP (EUS then ERCP), and Group C: ERCP with/without separate EUS (ERCP ± EUS). Rates of technical success, number of procedures, complications, and time to initiation of PDAC therapies were compared between groups., Results: Two hundred patients met study criteria. EUS/ERCP approach (Group A) had a longer index procedure duration (median 66 min, p = 0.023). No differences were observed between Group A versus sequential procedure approaches (Groups B and C) for complications (p = 0.109) and success of EUS-FNA (p = 0.711) and ERCP (p = 0.109). Subgroup analysis (> 2 months of follow-up, not referred to hospice, n = 126) was performed. No differences were observed for stent failure (p = 0.307) or need for subsequent procedures (p = 0.220). EUS/ERCP (Group A) was associated with a shorter time to initiation of PDAC therapies (mean, 25.2 vs 42.7 days, p = 0.046)., Conclusions: EUS/ERCP approach has comparable rates of success and complications compared to separate, sequential approaches. An EUS/ERCP approach equates to shorter time interval to initiation of PDAC therapies., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2021
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28. T1 mapping for the diagnosis of early chronic pancreatitis: correlation with Cambridge classification system.
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Cheng M, Gromski MA, Fogel EL, DeWitt JM, Patel AA, and Tirkes T
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- Adult, Aged, Female, Humans, Male, Middle Aged, Pancreas pathology, Pancreatic Ducts pathology, Pancreatitis, Chronic classification, Pancreatitis, Chronic pathology, Reference Standards, Retrospective Studies, Time Factors, Young Adult, Cholangiopancreatography, Magnetic Resonance methods, Imaging, Three-Dimensional methods, Pancreas diagnostic imaging, Pancreatic Ducts diagnostic imaging, Pancreatitis, Chronic diagnostic imaging
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Objective: This study aims to determine if T1 relaxation time of the pancreas can detect parenchymal changes in early chronic pancreatitis (CP)., Methods: This study retrospectively analyzed 42 patients grouped as no CP (Cambridge 0; n = 21), equivocal (Cambridge 1; n = 12) or mild CP (Cambridge 2; n = 9) based on magnetic resonance cholangiopancreatography findings using the Cambridge classification as the reference standard. Unenhanced T1 maps were acquired using a three-dimensional dual flip-angle gradient-echo technique on the same 1.5 T scanner with the same imaging parameters., Results: There was no significant difference between the T1 relaxation times of Cambridge 0 and 1 group ( p = 0.58). There was a significant difference ( p = 0.0003) in the mean T1 relaxation times of the pancreas between the combined Cambridge 0 and 1 (mean = 639 msec, 95% CI: 617, 660) and Cambridge 2 groups (mean = 726 msec, 95% CI: 692, 759). There was significant difference ( p = 0.0009) in the mean T1 relaxation times of the pancreas between the Cambridge 0 (mean = 636 msec, 95% CI: 606, 666) and Cambridge 2 groups (mean = 726 msec, 95% CI: 692,759) as well as between Cambridge 1 (mean = 643 msec, 95% CI: 608, 679) and Cambridge 2 groups (mean = 726 msec, 95% CI: 692,759) ( p = 0.0017). Bland-Altman analysis showed measurements of one reader to be marginally higher than the other by 15.7 msec (2.4%, p = 0.04)., Conclusion: T1 mapping is a practical method capable of quantitatively reflecting morphologic changes even in the early stages of chronic pancreatitis, and demonstrates promise for future implementation in routine clinical imaging protocols., Advances in Knowledge: T1 mapping can distinguish subtle parenchymal changes seen in early stage CP, and demonstrates promise for implementation in routine imaging protocols for the diagnosis of CP.
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- 2021
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29. Double high-level disinfection versus liquid chemical sterilization for reprocessing of duodenoscopes used for ERCP: a prospective randomized study.
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Gromski MA, Sieber MS, Sherman S, and Rex DK
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- Cholangiopancreatography, Endoscopic Retrograde, Disinfection, Equipment Contamination prevention & control, Humans, Prospective Studies, Cross Infection prevention & control, Duodenoscopes
- Abstract
Background and Aims: The potential for transmission of pathogenic organisms is a problem inherent to the current reusable duodenoscope design. Recent outbreaks of multidrug-resistant pathogenic organisms transmitted via duodenoscopes has brought to light the urgency of this problem. Microbiologic culturing of duodenoscopes and reprocessing with repeat high-level disinfection (HLD) or liquid chemical sterilization (LCS) have been offered as supplemental measures to enhance duodenoscope reprocessing by the U.S. Food and Drug Administration. This study aims to compare the efficacy of reprocessing duodenoscopes with double HLD (DHLD) versus LCS., Methods: We prospectively evaluated 2 different modalities of duodenoscope reprocessing from October 23, 2017 to September 24, 2018. Eligible duodenoscopes were randomly segregated to be reprocessed by either DHLD or LCS. Duodenoscopes were randomly cultured after reprocessing for surveillance based on an internal protocol., Results: During the study period, there were 878 post-reprocessing surveillance cultures (453 in the DHLD group and 425 in the LCS group). Of all cultures, 17 were positive for any organism (1.9%). There was no significant difference of positive cultures when comparing the duodenoscopes undergoing DHLD (8 positive cultures, 1.8%) with duodenoscopes undergoing LCS (9 positive cultures, 2.1%; P = .8). Both groups had 2 cultures that grew high-concern organisms (.5% vs .5%, P=1.0). No multidrug-resistant organisms, including carbapenem-resistant enterobacteriaceae, were detected., Conclusions: DHLD and LCS both resulted in a low rate of positive cultures, for all organisms and for high-concern organisms. However, neither process completely eliminated positive cultures from duodenoscopes reprocessed with 2 different supplemental reprocessing strategies., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2021
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30. Impact of Endoscopic Vacuum Therapy with Low Negative Pressure for Esophageal Perforations and Postoperative Anastomotic Esophageal Leaks.
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Jung CFM, Müller-Dornieden A, Gaedcke J, Kunsch S, Gromski MA, Biggemann L, Seif Amir Hosseini A, Ghadimi M, Ellenrieder V, and Wedi E
- Subjects
- Anastomotic Leak surgery, Esophagectomy, Humans, Retrospective Studies, Stents adverse effects, Treatment Outcome, Esophageal Perforation etiology, Esophageal Perforation surgery, Negative-Pressure Wound Therapy
- Abstract
Introduction: Management of esophageal anastomotic leaks (AL) and esophageal perforations (EP) remains difficult and often requires an interdisciplinary treatment modality. For primary endoscopic management, self-expanding metallic stent (SEMS) placement is often considered first-line therapy. Recently, endoscopic vacuum therapy (EVT) has emerged as an alternative or adjunct for management of these conditions. So far, data for EVT in the upper gastrointestinal-tract is restricted to single centre, non-randomized trials. No studies on optimal negative pressure application during EVT exist. The aim of our study is to describe our centre's experience with low negative pressure (LNP) EVT for these indications over the past 5-years., Patients and Methods: Between January 2014 and December 2018, 30 patients were endoscopically treated for AL (n = 23) or EP (n = 7). All patients were primarily treated with EVT and LNP between -20 and -50 mm Hg. Additional endoscopic treatment was added when EVT failed. Procedural and peri-procedural data, as well as clinical outcomes including morbidity and mortality, were analysed., Results: Clinical successful endoscopic treatment of EP and AL was achieved in 83.3% (n = 25/30), with 73.3% success using EVT alone (n = 22/30). Mean treatment duration until leak closure was 16.1 days (range 2-58 days). Additional treatment modalities for complete leak resolution was necessary in 10% (n = 3/30), including SEMS placement and fibrin glue injection. Mean hospital stay for patients with EP was shorter with 33.7 days compared to AL with 54.4 days (p = 0.08). Estimated preoperative 10-year overall survival (Charlson comorbidity score) was 39.4% in patients with AL and 59.9% in patients with EP (p = 0.26). A mean of 5.1 EVT changes (range 1-12) was needed in EP and 3.6 changes (range 1-13) in AL to achieve complete closure, switch to other treatment modality, or reach endoscopic failure (p = 0.38)., Conclusion: LNP EVT enables effective minimally - invasive endoluminal leak closure from anastomotic esophageal leaks and EP in high-morbid patients. In this study, EVT was combined with other endoscopic treatment options such as SEMS placement or fibrin glue injection in order to achieve leak or perforation closure in the vast majority of patients (83.3%). Low aspiration pressures led to slower but still sufficient clinical results., (© 2020 The Author(s) Published by S. Karger AG, Basel.)
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- 2021
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31. Gallstone pancreatitis: general clinical approach and the role of endoscopic retrograde cholangiopancreatography.
- Author
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Kundumadam S, Fogel EL, and Gromski MA
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- Acute Disease, Cholangiopancreatography, Endoscopic Retrograde, Cholecystectomy, Humans, Gallstones complications, Gallstones diagnostic imaging, Gallstones surgery, Pancreatitis diagnostic imaging, Pancreatitis etiology, Pancreatitis therapy
- Abstract
Gallstones account for majority of acute pancreatitis in the Western world. Increase in number and smaller size of the stones increases the risk for biliary pancreatitis. In addition to features of acute pancreatitis, these patients also have cholestatic clinical picture. Fluid therapy and enteral nutrition are vital components in management of any case of acute pancreatitis. During initial evaluation, a right upper quadrant ultrasonogram is particularly important. On a case-bycase basis, further advanced imaging studies such as magnetic resonance cholangiopancreatography or endoscopic ultrasound may be warranted. Acute management also involves monitoring for local and systemic complications. Patients are triaged based on predictors of ongoing biliary obstruction in order to identify who would need endoscopic retrograde cholangiopancreatography. Index cholecystectomy is safe and recommended, with exception of cases with significant local and systemic complications where delayed cholecystectomy may be safer.
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- 2021
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32. The continuum of complications in survivors of necrotizing pancreatitis.
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Maatman TK, Roch AM, Ceppa EP, Easler JJ, Gromski MA, House MG, Nakeeb A, Schmidt CM, Sherman S, and Zyromski NJ
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- Adolescent, Adult, Aged, Aged, 80 and over, Chronic Pain epidemiology, Chronic Pain etiology, Constriction, Pathologic epidemiology, Constriction, Pathologic etiology, Drainage adverse effects, Exocrine Pancreatic Insufficiency epidemiology, Exocrine Pancreatic Insufficiency etiology, Female, Follow-Up Studies, Gastric Fistula epidemiology, Gastric Fistula etiology, Humans, Incidence, Intestinal Fistula epidemiology, Intestinal Fistula etiology, Islets of Langerhans physiopathology, Male, Middle Aged, Pancreatectomy adverse effects, Pancreatitis, Acute Necrotizing mortality, Pancreatitis, Acute Necrotizing physiopathology, Pancreatitis, Acute Necrotizing therapy, Pancreatitis, Chronic epidemiology, Pancreatitis, Chronic etiology, Retrospective Studies, Splanchnic Circulation, Venous Thrombosis epidemiology, Venous Thrombosis etiology, Young Adult, Pancreatitis, Acute Necrotizing complications, Survivors statistics & numerical data
- Abstract
Background: Necrotizing pancreatitis survivors develop complications beyond infected necrosis that often require invasive intervention. Remarkably few data have cataloged these late complications after acute necrotizing pancreatitis resolution. We sought to identify the types and incidence of complications after necrotizing pancreatitis., Design: An observational study was performed evaluating 647 patients with necrotizing pancreatitis captured in a single-institution database between 2005 and 2017 at a tertiary care hospital. Retrospective review and analysis of newly diagnosed conditions attributable to necrotizing pancreatitis was performed. Exclusion criteria included the following: death before disease resolution (n = 57, 9%) and patients lost to follow-up (n = 12, 2%)., Results: A total of 578 patients were followed for a median of 46 months (range, 8 months to 15 y) after necrotizing pancreatitis. In 489 (85%) patients 1 or more complications developed and included symptomatic disconnected pancreatic duct syndrome (285 of 578, 49%), splanchnic vein thrombosis (257 of 572, 45%), new endocrine insufficiency (195 of 549, 35%), new exocrine insufficiency (108 of 571, 19%), symptomatic chronic pancreatitis (93 of 571, 16%), incisional hernia (89 of 420, 21%), biliary stricture (90 of 576, 16%), chronic pain (44 of 575, 8%), gastrointestinal fistula (44 of 578, 8%), pancreatic duct stricture (30 of 578, 5%), and duodenal stricture (28 of 578, 5%). During the follow-up period, a total of 340 (59%) patients required an invasive intervention after necrotizing pancreatitis resolution. Invasive pancreatobiliary intervention was required in 230 (40%) patients., Conclusion: Late complications are common in necrotizing pancreatitis survivors. A broad variety of problems manifest themselves after resolution of the acute disease process and often require invasive intervention. Necrotizing pancreatitis patients should be followed lifelong by experienced clinicians., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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33. A rare complication of ERCP: duodenal perforation due to biliary stent migration.
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Gromski MA, Bick BL, Vega D, Easler JJ, Watkins JL, Sherman S, Lehman GA, and Fogel EL
- Abstract
Background and study aims Perforation of the duodenal wall opposing the major papilla due to a migrated pancreatobiliary stent rarely has been described in the literature as a complication of endoscopic retrograde cholangiopancreatography (ERCP). Factors associated with perforation from migrated stents from ERCP are unknown. Patients and methods This was a retrospective, observational study. Patients were identified from January 1, 1994 to May 31, 2019 in a prospectively maintained ERCP database. Results Eleven cases of duodenal perforation from migrated pancreatobiliary stents placed at ERCP were identified during the study period. All cases involved biliary stents, placed for biliary stricture management. The perforating stent was plastic in 10 cases (91 %). This complication occurred in one in 2,293 ERCP procedures in which a pancreatobiliary stent was placed. Conclusion This complication is more common with biliary stents compared to pancreatic stents. This may be related to the angle of exit of biliary stents being more perpendicular to the opposing duodenal wall and the near exclusive use of external pigtail plastic stents in the pancreatic duct. All perforating plastic stents were ≥ 9 cm in length. Longer stents may provide leverage for perforation with a migration event., Competing Interests: Competing interests Dr. Lehman is a consultant for Cook Medical. Dr. Sherman is a consultant for Cook Medical, Olympus America, and Boston Scientific. Dr. Gromski is a consultant for Boston Scientific. Dr. Easler is a consultant for Boston Scientific., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
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- 2020
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34. Novel modified endoscopic mucosal resection of large GI lesions (> 20 mm) using an external additional working channel (AWC) may improve R0 resection rate: initial clinical experience.
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Sportes A, Cfm J, Gromski MA, Koehler P, Seif Amir Hosseini A, Kauffmann P, Ellenrieder V, and Wedi E
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- Aged, Endoscopic Mucosal Resection methods, Endoscopy, Gastrointestinal methods, Female, Gastrointestinal Neoplasms surgery, Humans, Male, Middle Aged, Pilot Projects, Treatment Outcome, Endoscopic Mucosal Resection instrumentation, Endoscopy, Gastrointestinal instrumentation, Gastric Mucosa surgery, Gastrointestinal Tract surgery, Intestinal Mucosa surgery
- Abstract
Background: En-bloc resection of large, flat dysplastic mucosal lesions of the luminal GI tract can be challenging. In order to improve the efficacy of resection for lesions ≥2 cm and to optimize R0 resection rates of lesions suspected of harboring high-grade dysplasia or early adenocarcinoma, a novel grasp and snare EMR technique utilizing a novel over the scope additional accessory channel, termed EMR Plus (EMR+), was developed. The aim of this pilot study is to describe the early safety and efficacy data from the first in human clinical cases., Methods: A novel external over-the-scope additional working channel (AWC) (Ovesco, Tuebingen, Germany) was utilized for the EMR+ procedure, allowing a second endoscopic device to be used through the AWC while using otherwise standard endoscopic equipment. The EMR+ technique allows tissue retraction and a degree of triangulation during endoscopic resection. We performed EMR+ procedure in 6 patients between 02/2018-12/2018 for lesions in the upper and lower GI tract., Results: The EMR+ technique utilizing the AWC was performed successfully in 6 resection procedures of the upper and/or lower GI tract in 6 patients in 2 endoscopy centers. All resections were performed successfully with the EMR+ technique, all achieving an R0 resection. No severe adverse events occurred in any of the procedures., Conclusions: The EMR+ technique, utilizing an additional working channel, had an acceptable safety and efficacy profile in this preliminary study demonstrating it's first use in humans. This technique may allow an additional option to providers to remove complex, large mucosal-based lesions in the GI tract using standard endoscopic equipment and a novel AWC device.
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- 2020
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35. Endoscopic Management of Post-Polypectomy Bleeding.
- Author
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Gutta A and Gromski MA
- Abstract
Post-polypectomy bleeding (PPB) is one of the most common complications of endoscopic polypectomy. There are multiple risk factors related to patient and polyp characteristics that should be considered. In most cases, immediate PPB can be effectively managed endoscopically when recognized and managed promptly. Delayed PPB can manifest in a myriad of ways. In severe delayed PPB, resuscitation for hemodynamic stabilization should be prioritized, followed by endoscopic evaluation and therapy once the patient is stabilized. Future areas of research in PPB include the risks of direct oral anticoagulants and of specific electrosurgical settings for hot-snare polypectomy vs. cold-snare polypectomy, benefits of closure of post-polypectomy mucosal defects using through-the-scope clips, and prospective comparative evaluation of newer hemostasis agents such as hemostatic spray powder and over-the-scope clips.
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- 2020
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36. Utility of DNA Profiling From Main Pancreatic Duct Fluid by Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography to Screen for Malignant Potential.
- Author
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Simpson RE, Flick KF, Gromski MA, Al-Haddad MA, Easler JJ, Sherman S, Fogel EL, Schmidt CM, and DeWitt JM
- Subjects
- Adult, Aged, Aged, 80 and over, Carcinoembryonic Antigen metabolism, Chromogranins genetics, DNA genetics, Female, GTP-Binding Protein alpha Subunits, Gs genetics, Humans, Male, Middle Aged, Mutation, Pancreatic Ducts metabolism, Pancreatic Neoplasms genetics, Pancreatic Neoplasms metabolism, Proto-Oncogene Proteins p21(ras) genetics, Retrospective Studies, Cholangiopancreatography, Endoscopic Retrograde methods, DNA analysis, Endoscopic Ultrasound-Guided Fine Needle Aspiration methods, Pancreatic Ducts pathology, Pancreatic Neoplasms pathology
- Abstract
Objectives: The yield of genetic testing of main pancreatic duct (MPD) fluid collected during endoscopic retrograde cholangiopancreatography (ERCP) versus endoscopic ultrasound-guided fine-needle aspiration is unclear., Methods: Consecutive MPD fluid samples obtained by endoscopic ultrasound/ERCP with DNA profiling were reviewed, excluding specimens designated "no amplification." Invasive disease included invasive cancer or malignant cytology., Results: One hundred ten samples from 109 patients who underwent ERCP (n = 32) or endoscopic ultrasound-guided fine-needle aspiration (n = 78) were analyzed (2007-2018). Leading indications were dilated MPD and suspected intraductal papillary mucinous neoplasm. Elevated DNA quantity, KRAS, loss of heterozygosity (LOH), and GNAS mutations occurred in 61.5%, 25.5%, 16.4%, and 8.7% of samples, respectively. Elevated DNA quantity occurred more frequently in ERCP samples (84.4% vs 51.9%, P = 0.002); other mutation yields were similar (P > 0.05). Invasive pathology (P = 0.032) was associated with LOH in the subset of patients who underwent surgery (n = 44). Adverse events occurred more frequently after ERCP (28.1% vs 9.0%, P = 0.016)., Conclusions: Endoscopic MPD fluid sampling may yield genetic data to improve diagnosis and risk stratification. In our surgical cohort, LOH was the sole predictor of invasive pathology. Endoscopic ultrasound-guided fine-needle aspiration of MPD fluid, when possible, is preferred because of superior safety profile.
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- 2020
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37. Endoscopic submucosal dissection: a cognitive task analysis framework toward training design.
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Hegde S, Gromski MA, Halic T, Turkseven M, Xia Z, Çetinsaya B, Sawhney MS, Jones DB, De S, and Jackson CD
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- Clinical Decision-Making, Cognition, Computer Simulation, Ergonomics, Humans, Models, Anatomic, Psychology, Educational, Task Performance and Analysis, Education methods, Education standards, Endoscopic Mucosal Resection methods, Endoscopic Mucosal Resection psychology
- Abstract
Background: One of the major impediments to the proliferation of endoscopic submucosal dissection (ESD) training in Western countries is the lack of sufficient experts as instructors. One way to address this gap is to develop didactic systems, such as surgical simulators, to support the role of trainers. Cognitive task analysis (CTA) has been used in healthcare for the design and improvement of surgical training programs, and therefore can potentially be used for design of similar systems for ESD., Objective: The aim of the study was to apply a CTA-based approach to identify the cognitive aspects of performing ESD, and to generate qualitative insights for training., Materials and Methods: Semi-structured interviews were designed based on the CTA framework to elicit knowledge of ESD practitioners relating to the various tasks involved in the procedure. Three observations were conducted of expert ESD trainers either while they performed actual ESD procedures or at a training workshop. Interviews were either conducted over the phone or in person. Interview participants included four experts and four novices. The observation notes and interviews were analyzed for emergent qualitative themes and relationships., Results: The qualitative analysis yielded thematic insights related to four main cognition-related categories: learning goals/principles, challenges/concerns, strategies, and decision-making. The specific insights under each of these categories were systematically mapped to the various tasks inherent to the ESD procedure., Conclusions: The CTA approach was applied to identify cognitive themes related to ESD procedural tasks. Insights developed based on the qualitative analysis of interviews and observations of ESD practitioners can be used to inform the design of ESD training systems, such as virtual reality-based simulators.
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- 2020
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38. Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: a double-blind, randomised controlled trial.
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Fogel EL, Lehman GA, Tarnasky P, Cote GA, Schmidt SE, Waljee AK, Higgins PDR, Watkins JL, Sherman S, Kwon RSY, Elta GH, Easler JJ, Pleskow DK, Scheiman JM, El Hajj II, Guda NM, Gromski MA, McHenry L Jr, Arol S, Korsnes S, Suarez AL, Spitzer R, Miller M, Hofbauer M, and Elmunzer BJ
- Subjects
- Administration, Rectal, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Pancreatitis epidemiology, Pancreatitis etiology, Retrospective Studies, Risk Factors, Severity of Illness Index, Treatment Outcome, United States epidemiology, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Indomethacin administration & dosage, Pancreatitis prevention & control
- Abstract
Background: Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients., Methods: In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete., Findings: Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients-76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87-1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients-six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up., Interpretation: Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP., Funding: American College of Gastroenterology., (Copyright © 2020 Elsevier Ltd. All rights reserved.)
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- 2020
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39. End of the Road for Epinephrine Spraying of the Papilla to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis?
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Gromski MA and Fogel EL
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- Epinephrine, Humans, Indomethacin, Cholangiopancreatography, Endoscopic Retrograde, Pancreatitis
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- 2019
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40. Recent advances in the diagnosis and management of chronic pancreatitis.
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Kwon CI, Cho JH, Choi SH, Ko KH, Tirkes T, Gromski MA, and Lehman GA
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- Disease Management, Humans, Pancreatitis, Chronic diagnostic imaging, Pancreatitis, Chronic therapy
- Abstract
Chronic pancreatitis is a chronic condition characterized by pancreatic inflammation that causes fibrosis and the destruction of exocrine and endocrine tissues. Chronic pancreatitis is a progressive disease, and no physiological treatment is available to reverse its course. However, with advances in medical technology, the existing diagnostic and treatment methods for chronic pancreatitis are evolving. Managing patients with chronic pancreatitis is challenging and necessitates a multidisciplinary approach. In this review, we discuss the recent advances in the diagnosis and management of chronic pancreatitis and introduce future alternative modalities.
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- 2019
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41. A task and performance analysis of endoscopic submucosal dissection (ESD) surgery.
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Cetinsaya B, Gromski MA, Lee S, Xia Z, Demirel D, Halic T, Bayrak C, Jackson C, De S, Hegde S, Cohen J, Sawhney M, Stavropoulos SN, and Jones DB
- Subjects
- Clinical Competence, Dissection, Endoscopic Mucosal Resection instrumentation, Endoscopic Mucosal Resection methods, Humans, Software Design, Endoscopic Mucosal Resection education, Simulation Training, Task Performance and Analysis
- Abstract
Background: ESD is an endoscopic technique for en bloc resection of gastrointestinal lesions. ESD is a widely-used in Japan and throughout Asia, but not as prevalent in Europe or the US. The procedure is technically challenging and has higher adverse events (bleeding, perforation) compared to endoscopic mucosal resection. Inadequate training platforms and lack of established training curricula have restricted its wide acceptance in the US. Thus, we aim to develop a Virtual Endoluminal Surgery Simulator (VESS) for objective ESD training and assessment. In this work, we performed task and performance analysis of ESD surgeries., Methods: We performed a detailed colorectal ESD task analysis and identified the critical ESD steps for lesion identification, marking, injection, circumferential cutting, dissection, intraprocedural complication management, and post-procedure examination. We constructed a hierarchical task tree that elaborates the order of tasks in these steps. Furthermore, we developed quantitative ESD performance metrics. We measured task times and scores of 16 ESD surgeries performed by four different endoscopic surgeons., Results: The average time of the marking, injection, and circumferential cutting phases are 203.4 (σ: 205.46), 83.5 (σ: 49.92), 908.4 s. (σ: 584.53), respectively. Cutting the submucosal layer takes most of the time of overall ESD procedure time with an average of 1394.7 s (σ: 908.43). We also performed correlation analysis (Pearson's test) among the performance scores of the tasks. There is a moderate positive correlation (R = 0.528, p = 0.0355) between marking scores and total scores, a strong positive correlation (R = 0.7879, p = 0.0003) between circumferential cutting and submucosal dissection and total scores. Similarly, we noted a strong positive correlation (R = 0.7095, p = 0.0021) between circumferential cutting and submucosal dissection and marking scores., Conclusions: We elaborated ESD tasks and developed quantitative performance metrics used in analysis of actual surgery performance. These ESD metrics will be used in future validation studies of our VESS simulator.
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- 2019
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42. Annular pancreas: endoscopic and pancreatographic findings from a tertiary referral ERCP center.
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Gromski MA, Lehman GA, Zyromski NJ, Watkins JL, El Hajj II, Tan D, McHenry L, Easler JJ, Tirkes T, Sherman S, and Fogel EL
- Subjects
- Adolescent, Adult, Aged, Bile Duct Neoplasms diagnosis, Child, Child, Preschool, Endoscopy, Digestive System, Female, Humans, Male, Middle Aged, Pancreatic Neoplasms diagnosis, Pancreatitis, Chronic diagnosis, Retrospective Studies, Sphincter of Oddi Dysfunction diagnosis, Tertiary Care Centers, Young Adult, Cholangiopancreatography, Endoscopic Retrograde, Cholangiopancreatography, Magnetic Resonance, Pancreas abnormalities, Pancreatic Diseases diagnosis
- Abstract
Background and Aims: Annular pancreas is a congenital anomaly whereby pancreatic tissue encircles the duodenum. Current knowledge of endoscopic findings of annular pancreas is limited to small case series. The aim of this study was to describe the endoscopic and pancreatographic findings of patients with annular pancreas at a large tertiary care ERCP center., Methods: This is a retrospective observational study. Our Institutional Review Board-approved, prospectively collected ERCP database was queried for cases of annular pancreas. The electronic medical records were searched for patient and procedure-related data., Results: From January 1, 1994, to December 31, 2016, 46 patients with annular pancreas underwent ERCP at our institution. Index ERCP was technically successful in 42 patients (91.3%), and technical success was achieved in all 46 patients (100%) after 2 attempts, when required. A duodenal narrowing or ring was found in most patients (n = 39, 84.8%), yet only 2 (4.3%) had retained gastric contents. Pancreas divisum was found in 21 patients (45.7%), 18 of which were complete divisum. Pancreatobiliary neoplasia was the indication for ERCP in 7 patients (15.2%). Pancreatographic findings consistent with chronic pancreatitis were noted in 15 patients (32.6%) at the index ERCP., Conclusion: This is the largest series describing the endoscopic and pancreatographic findings of patients with annular pancreas. We found that 45.7% of patients had concurrent pancreas divisum. Endoscopic therapy was successful in most patients at our institution after 1 ERCP, and in all patients after a second ERCP. Nearly one-third of patients had findings consistent with chronic pancreatitis at the time of index ERCP. It is unclear whether this may be a feature of the natural history of annular pancreas., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2019
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43. Clinical outcomes of FOLFIRINOX in locally advanced pancreatic cancer: A single center experience.
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Lee J, Lee JC, Gromski MA, Kim HW, Kim J, Kim J, and Hwang JH
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- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols standards, Chemoradiotherapy methods, Chemoradiotherapy standards, Drug Combinations, Female, Fluorouracil therapeutic use, Humans, Irinotecan, Leucovorin therapeutic use, Male, Middle Aged, Organometallic Compounds therapeutic use, Oxaliplatin, Pancreatic Neoplasms mortality, Pancreatic Neoplasms surgery, Republic of Korea, Survival Analysis, Treatment Outcome, Fluorouracil standards, Leucovorin standards, Organometallic Compounds standards, Pancreatic Neoplasms drug therapy
- Abstract
Systemic chemotherapy or chemoradiotherapy is the initial primary option for patients with locally advanced pancreatic cancer (LAPC). This study analyzed the effect of FOLFIRINOX and assessed the factors influencing conversion to surgical resectability for LAPC.Sixty-four patients with LAPC who received FOLFIRINOX as initial chemotherapy were enrolled retrospectively. Demographic characteristics, tumor status, interval/dosage/cumulative relative dose intensity (cRDI) of FOLFIRINOX, conversion to resection, and clinical outcomes were reviewed and factors associated with conversion to resectability after FOLFIRINOX were analyzed.After administration of FOLFIRINOX (median 9 cycles, 70% of cRDI), the median patient overall survival (OS) was 17.0 months. Fifteen of 64 patients underwent surgery and R0 resection was achieved in 11 patients. During a median follow-up time of 9.4 months after resection, cumulative recurrence rate was 28.5% at 18 months after resection. The estimated median OS was significantly longer for the resected group (>40 months vs 13 months). There were no statistical differences between the resected and non-resected groups in terms of baseline characteristics, tumor status and hematologic adverse effects. The patients who received standard dose of FOLFIRINOX had higher probability of subsequent resection compared with patients who received reduced dose, although cRDIs did not differ between groups.FOLFIRINOX is an active regimen in patients with LAPC, given acceptable resection rates and promising R0 resection rates. Additionally, our data demonstrate it is advantageous for obtaining resectability to administer FOLFIRINOX without dose reduction.
- Published
- 2018
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44. Prospective Assessment of the Performance of a New Fine Needle Biopsy Device for EUS-Guided Sampling of Solid Lesions.
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El Hajj II, Wu H, Reuss S, Randolph M, Harris A, Gromski MA, and Al-Haddad M
- Abstract
Background/aims: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) remains the most common EUS-guided tissue acquisition technique. This study aimed to evaluate the performance of a new Franseen tip fine needle biopsy (FNB) device for EUSguided sampling of solid lesions and compare it with the historical FNA technique., Methods: Acquire® 22 G FNB needle (Boston Scientific Co., Natick, MA, USA) was used for solid tumor sampling (Study group). Tissue was collected for rapid on-site evaluation, and touch and crush preparations were made. Historical EUS-FNA samples obtained using Expect® 22 G FNA needle (Boston Scientific Co.) were used as controls (Control group). All specimens were independently evaluated by two cytopathologists blinded to the formal cytopathological diagnosis., Results: Mean cell block histology scores were significantly higher (p=0.046) in the FNB group (51 samples) despite a significantly lower (p<0.001) mean number of passes compared to the FNA group (50 specimens). The overall diagnostic yields for the FNB vs. FNA groups were 96% vs. 88%. The degree of tumor differentiation was adequately assessed in all cell block qualifying lesions in the FNB group. Two patients developed post-FNB abdominal pain., Conclusion: The new Franseen tip FNB device provides histologically superior and cytologically comparable specimens to those obtained by FNA, but with fewer passes.
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- 2018
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45. Impact of the development of an endoscopic eradication program for Barrett's esophagus with high grade dysplasia or early adenocarcinoma on the frequency of surgery.
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Chilukuri P, Gromski MA, Johnson CS, Ceppa DKP, Kesler KA, Birdas TJ, Rieger KM, Fatima H, Kessler WR, Rex DK, Al-Haddad M, and DeWitt JM
- Abstract
Background and aims The impact of the advent of an institutional endoscopic eradication therapy (EET) program on surgical practice for Barrett's esophagus (BE)-associated high grade dysplasia (HGD) or suspected T1a esophageal adenocarcinoma (EAC) is unknown. The aims of this study are to evaluate the different endoscopic modalities used during development of our EET program and factors associated with the use of EET or surgery for these patients after its development. Methods Patients who underwent primary endoscopic or surgical treatment for BE-HGD or early EAC at our hospital between January 1992 and December 2014 were retrospectively identified. They were categorized by their initial modality of treatment during the first year, and the impact over time for choice of therapy was assessed by multivariable logistic regression. Results We identified 386 patients and 80 patients who underwent EET and surgery, respectively. EET included single modality therapy in 254 (66 %) patients and multimodal therapy in 132 (34 %) patients. Multivariable logistic regression showed that, for each subsequent study year, EET was more likely to be performed in patients who were older ( P = 0.0009), with shorter BE lengths ( P < 0.0001), and with a pretreatment diagnosis of HGD ( P = 0.0054) compared to surgical patients. The diagnosis of EAC did not increase the utilization of EET compared to surgery as time progressed ( P = 0.8165). Conclusion The introduction of an EET program at our hospital increased the odds of utilizing EET versus surgery over time for initial treatment of patients who were older, had shorter BE lengths or the diagnosis of BE-HGD, but not in patients with EAC.
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- 2018
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46. Additional flap on plastic stents for improved antimigration effect in the treatment of post-cholecystectomy bile leak.
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Kwon CI, Gromski MA, Oh HC, Easler JJ, El Hajj II, Watkins J, Fogel EL, McHenry L, Sherman S, and Lehman GA
- Abstract
Background and Study Aims: In plastic stent insertion for treatment of post-cholecystectomy bile leak, stent migration may be more common due to the absence of a shelf to anchor the stent. We evaluated how adding a flap to straight plastic stents for this indication might influence the rate of stent migration when compared to use of conventional plastic stents., Patients and Methods: This is a retrospective study including patients referred for ERCP for treatment of post-cholecystectomy bile leak. Patients with a customized anti-migration flap stent had the additional flap created on the distal end of straight plastic stents, intended to aid in anchoring in the distal supra-sphincteric biliary duct. The primary endpoint is stent migration events. The secondary endpoint is bile leak resolution after first ERCP session., Results: Thirty-two patients were treated with the experimental additional flap stents and 225 patients were treated with standard straight biliary stents. The total failure rate of bile leak resolution after a single endoscopic treatment for all treated was 10.5 % (27/257) and the total stent migration rate for all enrolled was 15.2 % (39/257). Stent migration rate was lower in the additional flap stent group than in the conventional group (3.1 % vs. 16.9 %, respectively, P = 0.04). Furthermore, significantly more patients had resolution of their bile leak after the first ERCP session in the group with the additional flap (100 % vs. 88 %, respectively, P = 0.03)., Conclusion: A plastic biliary stent with an extra flap may have improved performance with regard to stent migration and resolution of bile leak over standard plastic biliary stents.
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- 2018
- Full Text
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47. Accidental fracture of an EUS-FNA needle.
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El Hajj II, Gromski MA, Lehman GA, Easler JJ, and Sherman S
- Subjects
- Aged, Humans, Male, Pancreas pathology, Biopsy, Fine-Needle adverse effects, Endoscopic Ultrasound-Guided Fine Needle Aspiration adverse effects, Equipment Failure, Needles adverse effects
- Published
- 2018
- Full Text
- View/download PDF
48. Learning colorectal endoscopic submucosal dissection: a prospective learning curve study using a novel ex vivo simulator.
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Gromski MA, Cohen J, Saito K, Gonzalez JM, Sawhney M, Kang C, Moore A, and Matthes K
- Subjects
- Animals, Clinical Competence, Colonoscopy methods, Endoscopic Mucosal Resection methods, Learning Curve, Operative Time, Prospective Studies, Rectum surgery, Swine, Colonoscopy education, Endoscopic Mucosal Resection education, Intestinal Mucosa surgery, Simulation Training
- Abstract
Background: Endoscopic submucosal dissection (ESD) is increasingly being used in Asia as a minimally invasive therapy to eradicate large laterally spreading superficial tumors in the colon. To date, the learning curve and effectiveness of ex vivo simulators in colonic ESD training remain unclear. The aim of the study is to determine the learning curve of colonic ESD in an ex vivo simulator., Methods: We conducted a prospective study of colon ESD in ex vivo porcine colons in a prototype simulator. Three endoscopists with prior experience in gastric ESD but with no experience in colonic ESD each performed 30 ESD resections on standardized lesions in the rectosigmoid and left colon of the porcine simulator. Procedure time, en bloc resection status, and perforation were recorded., Results: All 90 lesions were resected using the ESD technique. The mean time of procedure was 49.6 min (standard deviation 29.6 min). The aggregate rate of perforation was 14.4% and the aggregate rate of non-en bloc resection was 5.6%. Using a composite quality score integrating complications and procedural time, it was found that there was a significant difference between two local polynomial regression lines when using a cut-point at the 9th procedure (p = 0.04), reflecting the point at which most of the learning curve is traversed., Conclusions: In this study, there were significant improvements realized in colonic ESD performance after 9 colon ESD procedures in ex vivo specimens. Although training will depend on endoscopist skill and expertise, we suggest at least 9 ex vivo procedures prior to moving to live animal or proctored training in colonic ESD.
- Published
- 2017
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49. Clinical response to dorsal duct drainage via the minor papilla in refractory obstructing chronic calcific pancreatitis.
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Kwon CI, Gromski MA, Sherman S, El Hajj II, Easler JJ, Watkins J, McHenry L, Lehman GA, and Fogel EL
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- Abdominal Pain etiology, Adult, Aged, Calculi complications, Female, Humans, Male, Middle Aged, Pancreatitis, Chronic etiology, Recurrence, Retreatment, Stents, Calculi therapy, Drainage methods, Endoscopy, Digestive System methods, Pancreatic Ducts, Pancreatitis, Chronic therapy
- Abstract
Background and study aims Complete stone removal from the main pancreatic duct might not be achieved in all patients with obstructive chronic calcific pancreatitis. We report our results for endoscopic dorsal pancreatic duct (DPD) bypass of obstructing stones in the ventral pancreatic duct (VPD). Patients and methods 16 patients with obstructive chronic calcific pancreatitis were treated with a DPD bypass. Clinical success was defined as significant pain relief and no hospital admissions for pain management during the ongoing treatment period. Results Among 16 patients meeting entry criteria, 10 (62.5 %) had a history of unsuccessful endoscopic therapy, and 8 had failed extracorporeal shockwave lithotripsy (ESWL). Clinical success was achieved in 12 patients (75 %). Among these responders, 10 patients (83.3 %) had markedly improved or complete pain relief after the first stent placement, which persisted throughout the follow-up period; 11 patients (91.7 %) were able to discontinue their daily analgesics. Conclusions In selected patients with obstructive chronic calcific pancreatitis, the DPD bypass may be considered as a rescue endoscopic therapy, potentially obviating the need for surgery when standard endoscopic methods and ESWL fail., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2017
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50. Secondary Sclerosing Cholangitis From Spontaneous Choledochoduodenal Fistula.
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Gromski MA, Fogel EL, and Vuppalanchi R
- Subjects
- Adult, Duodenoscopy, Female, Fluoroscopy, Humans, Radiography, Abdominal, Cholangitis, Sclerosing diagnosis, Cholangitis, Sclerosing pathology, Common Bile Duct pathology, Duodenum pathology, Fistula complications
- Published
- 2017
- Full Text
- View/download PDF
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