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Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ =.363, P =.049). The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.) [Display omitted] [ABSTRACT FROM AUTHOR] more...

The indications for endotracheal intubation (ETI) during an esophagogastroduodenoscopy (EGD) procedure remain unclear. This study performed a descriptive analysis of patients who underwent prophylactic tracheal intubation during or before an EGD to prevent pulmonary aspiration. We selected patients with an upper gastrointestinal bleed in an intensive care unit who underwent EGD between 2000 and 2013. Eighty-nine patients who underwent pre-EGD tracheal intubation were analyzed. The main outcomes in this study were pulmonary aspiration, length of stay, and mortality. The average age of patients undergoing pre-EGD intubation was 61 years. The incidence of pulmonary aspiration was 38% in patients who underwent pre-EGD tracheal intubation. The patients requiring tracheal intubation had a mortality rate of 22% during hospitalization. Other complications in pre-EGD ETI patients included myocardial infarction (9%), acute respiratory distress syndrome (10%), and pulmonary edema (7%). In conclusion, the incidence of pulmonary aspiration with pre-EGD tracheal intubation in our patients was high (38%). Cardiopulmonary complications including myocardial infarction, acute respiratory distress syndrome, and pulmonary edema were high in intubated patients. [ABSTRACT FROM AUTHOR] more...

For oesophageal cancer patients with potentially curative disease, treatment usually comprises neoadjuvant chemoradiotherapy followed by surgery. Several methods are currently used for nutritional support while patients are undergoing neoadjuvant treatment but these do not relieve dysphagia. Stenting as a bridge to curative surgery has been explored in several case series and a case control study. This is a review of the current literature on the topic. Some small series have shown it to be safe and effective in relieving dysphagia and malnutrition without adverse effect on surgical outcomes, perioperative complications or delay in surgical resection post neoadjuvant therapy. However, there are sufficient concerns about its adverse impact on oncological outcomes such as a reduction in the R0 resection rates, median time to recurrence and 2 - 3 year overall survival, to not currently recommend its routine use in resectable cancers. [ABSTRACT FROM AUTHOR] more...

Introduction Telecytopathology for endoscopic ultrasound–guided fine-needle aspiration (EUS-FNA) has been shown to be an alternative to rapid on-site evaluation (ROSE). Gastroenterologists (endosonographers) performing EUS-FNA can be trained to evaluate a specimen for adequacy. This study examined the ability of an endosonographer with focused cytopathologic training to assess the adequacy of pancreatic FNA specimens and transmit diagnostic images to a remotely located cytopathologist as compared to an experienced cytotechnologist. Materials and methods This was a retrospective study of consecutive pancreatic lesions sampled by EUS-FNA reviewed by an endosonographer and a cytotechnologist. The participants were assessed based on their ability to (1) determine adequacy, (2) locate and transmit representative cell groups, (3) provide a preliminary diagnosis, and (4) provide concordance with actual diagnosis. Results 105 consecutive cases of EUS-FNA of the pancreas were analyzed, including: adenocarcinoma (n = 39), cyst (n = 17), neuroendocrine neoplasia (n = 7), pancreatitis (n = 14), benign pancreas (n = 9), other neoplasms (n = 6), suspicious/atypical (n = 3), and nondiagnostic (n = 10). The cytotechnologist demonstrated superiority in accuracy 92.7% versus 70% ( P = 0.003) and subcategorization 95.0% versus 76% ( P = 0.007). There was no difference in “broad” categorization (benign/malignant) between the endosonographer and cytotechnologist, 98% and 98.2% ( P = 0.946), respectively. Also, there was no difference with regard to adequacy assessment ( P = 0.29). A steady learning curve for the endosonographer was demonstrated in their cytologic assessment ( P = 0.041). The endosonographer was shown to be able to remotely transmit diagnostic images to a pathologist. Conclusion An endosonographer with limited training can examine for specimen adequacy, transmit images, and demonstrate representative cell groups. Larger studies are required though preliminary results are encouraging. [ABSTRACT FROM AUTHOR] more...

Next-generation sequencing (NGS) of pancreatic cyst fluid is a useful adjunct in the assessment of patients with pancreatic cyst. However, previous studies have been retrospective or single institutional experiences. The aim of this study was to prospectively evaluate NGS on a multi-institutional cohort of patients with pancreatic cyst in real time. The performance of a 22-gene NGS panel (PancreaSeq) was first retrospectively confirmed and then within a 2-year timeframe, PancreaSeq testing was prospectively used to evaluate endoscopic ultrasound–guided fine-needle aspiration pancreatic cyst fluid from 31 institutions. PancreaSeq results were correlated with endoscopic ultrasound findings, ancillary studies, current pancreatic cyst guidelines, follow-up, and expanded testing (Oncomine) of postoperative specimens. Among 1933 PCs prospectively tested, 1887 (98%) specimens from 1832 patients were satisfactory for PancreaSeq testing. Follow-up was available for 1216 (66%) patients (median, 23 months). Based on 251 (21%) patients with surgical pathology, mitogen-activated protein kinase/ GNAS mutations had 90% sensitivity and 100% specificity for a mucinous cyst (positive predictive value [PPV], 100%; negative predictive value [NPV], 77%). On exclusion of low-level variants, the combination of mitogen-activated protein kinase/ GNAS and TP53/SMAD4/CTNNB1/ mammalian target of rapamycin alterations had 88% sensitivity and 98% specificity for advanced neoplasia (PPV, 97%; NPV, 93%). Inclusion of cytopathologic evaluation to PancreaSeq testing improved the sensitivity to 93% and maintained a high specificity of 95% (PPV, 92%; NPV, 95%). In comparison, other modalities and current pancreatic cyst guidelines, such as the American Gastroenterology Association and International Association of Pancreatology/Fukuoka guidelines, show inferior diagnostic performance. The sensitivities and specificities of VHL and MEN1 /loss of heterozygosity alterations were 71% and 100% for serous cystadenomas (PPV, 100%; NPV, 98%), and 68% and 98% for pancreatic neuroendocrine tumors (PPV, 85%; NPV, 95%), respectively. On follow-up, serous cystadenomas with TP53 / TERT mutations exhibited interval growth, whereas pancreatic neuroendocrine tumors with loss of heterozygosity of ≥3 genes tended to have distant metastasis. None of the 965 patients who did not undergo surgery developed malignancy. Postoperative Oncomine testing identified mucinous cysts with BRAF fusions and ERBB2 amplification, and advanced neoplasia with CDKN2A alterations. PancreaSeq was not only sensitive and specific for various pancreatic cyst types and advanced neoplasia arising from mucinous cysts, but also reveals the diversity of genomic alterations seen in pancreatic cysts and their clinical significance. ▪ [ABSTRACT FROM AUTHOR] more...

Background and Aims EUS-guided biliary drainage is a technique being increasingly used when ERCP fails, and it has been the focus of multiple studies and investment in recent years. However, the proportion of cases for which it is really indicated has not been established. The aim of this study is to determine how often EUS-guided biliary drainage is needed in a tertiary-care level therapeutic endoscopy unit. Methods This is a prospective cohort study at a single tertiary-care center with a high volume of therapeutic endoscopy. A thousand consecutive ERCPs performed from November 1, 2013 to September 12, 2014 were screened, and those with previous biliary intervention were excluded (n = 476). EUS-guided biliary drainage was performed in suitable patients with failed ERCP and malignant biliary obstruction. The main outcome measures were the rates of ERCP failure and EUS-guided biliary drainage. Results A total of 524 native papilla ERCPs were performed (41.2% male; median age 60 years, range 6-97 years; 9.4% outside failed ERCP; 1.9% surgically altered anatomy). The ampulla was reached in 518 (98.9%) and not reached in 6 (1.1%) because of surgically altered anatomy (n = 2), malignant duodenal stenosis (n = 3), or both (n = 1). The overall ERCP failure rate was 1.7% (9/524). Cannulation was successful in 99.4% (515/518) and unsuccessful in 0.6% (3/518) of cases in which the ampulla was reached. EUS-guided biliary drainage was indicated in 0.6% (3/524) of all referred native papilla ERCPs, or 33% (3/9) of those patients with failed ERCP; EUS-biliary drainage was successful in all cases. Conclusions In a tertiary-care center, use of advanced ERCP techniques results in a high technical success rate. EUS-guided biliary drainage was required in only 0.6% of native papilla ERCPs, and although a number of excellent indications exist, it should not replace good ERCP technique. [ABSTRACT FROM AUTHOR] more...

Background & Aims Infected necrotizing pancreatitis is a highly morbid disease with poor outcomes. Intervention strategies have progressed from open necrosectomy to minimally invasive approaches. We compared outcomes of minimally invasive surgery vs endoscopic approaches for patients with infected necrotizing pancreatitis. Methods We performed a single-center, randomized trial of 66 patients with confirmed or suspected infected necrotizing pancreatitis who required intervention from May 12, 2014, through March 24, 2017. Patients were randomly assigned to groups that received minimally invasive surgery (laparoscopic or video-assisted retroperitoneal debridement, depending on location of collection, n = 32) or an endoscopic step-up approach (transluminal drainage with or without necrosectomy, n = 34). The primary endpoint was a composite of major complications (new-onset multiple organ failure, new-onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, bleeding and perforation of a visceral organ) or death during 6 months of follow-up. Results The primary endpoint occurred in 11.8% of patients who received the endoscopic procedure and 40.6% of patients who received the minimally invasive surgery (risk ratio 0.29; 95% confidence interval 0.11–0.80; P =.007). Although there was no significant difference in mortality (endoscopy 8.8% vs surgery 6.3%; P =.999), none of the patients assigned to the endoscopic approach developed enteral or pancreatic-cutaneous fistulae compared with 28.1% of the patients who underwent surgery (P =.001). The mean number of major complications per patient was significantly higher in the surgery group (0.69 ± 1.03) compared with the endoscopy group (0.15 ± 0.44) (P =.007). The physical health scores for quality of life at 3 months was better with the endoscopic approach (P =.039) and mean total cost was lower ($75,830) compared with $117,492 for surgery (P =.039). Conclusions In a randomized trial of 66 patients, an endoscopic transluminal approach for infected necrotizing pancreatitis, compared with minimally invasive surgery, significantly reduced major complications, lowered costs, and increased quality of life. Clinicaltrials.gov no: NCT02084537 Graphical abstract [ABSTRACT FROM AUTHOR] more...

Background Endoscopic ampullectomy is a technically challenging, high-risk procedure with limited training opportunities. Although simulation models can assist with endoscopic skill acquisition, an ampullectomy model does not currently exist. Objective To develop a training model that can be used to improve technical skills, knowledge, and confidence in performing endoscopic ampullectomy. Design Experimental study. Setting Tertiary hospital innovation laboratory. Subjects Twenty-one endoscopists attending an endoscopic resection workshop. Interventions A prototype for endoscopic ampullectomy was created by computer-aided design and 3-dimensional printing of an ampullary mount and base to which a chicken heart was attached and inserted into a silicone stomach-duodenum model. Study participants performed an ampullectomy and evaluated the prototype with a pre- and postampullectomy questionnaire by using a scale of 1 to 5 (very low to very high). Main Outcome Measurements Evaluation of core procedural steps, technical and visual realism, and proceduralist technical knowledge and confidence. Results Sixteen endoscopists participated in the study. All core procedural steps were completed by 14 participants. The mean overall technical and visual realism scores were 3.1 (standard deviation [SD], 0.9) and 3.2 (SD, 0.9), respectively. Ten participants (10/15, 66.7%) thought that their technical knowledge had improved, and 11 thought that it would increase further with additional sessions (11/15, 73.3%). Mean confidence score before and after using the model was 2.2 (SD, 1.2) and 2.9 (SD, 1.1), respectively ( P = .132). Limitations Pilot study, lack of follow-up of participants’ endoscopic practice after model experience. Conclusion Although further studies are necessary for validation, this novel prototype appears useful for endoscopic ampullectomy training. [ABSTRACT FROM AUTHOR] more...

Background Endoscopic ampullectomy is a technically challenging, high-risk procedure with limited training opportunities. Although simulation models can assist with endoscopic skill acquisition, an ampullectomy model does not currently exist. Objective To develop a training model that can be used to improve technical skills, knowledge, and confidence in performing endoscopic ampullectomy. Design Experimental study. Setting Tertiary hospital innovation laboratory. Subjects Twenty-one endoscopists attending an endoscopic resection workshop. Interventions A prototype for endoscopic ampullectomy was created by computer-aided design and 3-dimensional printing of an ampullary mount and base to which a chicken heart was attached and inserted into a silicone stomach-duodenum model. Study participants performed an ampullectomy and evaluated the prototype with a pre- and postampullectomy questionnaire by using a scale of 1 to 5 (very low to very high). Main Outcome Measurements Evaluation of core procedural steps, technical and visual realism, and proceduralist technical knowledge and confidence. Results Sixteen endoscopists participated in the study. All core procedural steps were completed by 14 participants. The mean overall technical and visual realism scores were 3.1 (standard deviation [SD], 0.9) and 3.2 (SD, 0.9), respectively. Ten participants (10/15, 66.7%) thought that their technical knowledge had improved, and 11 thought that it would increase further with additional sessions (11/15, 73.3%). Mean confidence score before and after using the model was 2.2 (SD, 1.2) and 2.9 (SD, 1.1), respectively ( P = .132). Limitations Pilot study, lack of follow-up of participants’ endoscopic practice after model experience. Conclusion Although further studies are necessary for validation, this novel prototype appears useful for endoscopic ampullectomy training. [ABSTRACT FROM AUTHOR] more...