Search

Background Esophageal adenocarcinoma (EAC) is a molecularly heterogeneous disease with poor prognosis that is rising rapidly in incidence. We aimed to demonstrate specific binding by a peptide heterodimer to Barrett’s neoplasia in human subjects. Methods Peptide monomers specific for EGFR and ErbB2 were arranged in a heterodimer configuration and labeled with IRDye800. This near-infrared (NIR) contrast agent was topically administered to patients with Barrett’s esophagus (BE) undergoing either endoscopic therapy or surveillance. Fluorescence images were collected using a flexible fiber accessory passed through the instrument channel of an upper gastrointestinal endoscope. Fluorescence images were collected from 31 BE patients. A deep learning model was used to segment the target (T) and background (B) regions. Results The mean target-to-background (T/B) ratio was significantly greater for high grade dysplasia (HGD) and EAC versus BE, low grade dysplasia (LGD), and squamous epithelium. At a T/B ratio of 1.5, sensitivity and specificity of 94.1 % and 92.6 %, respectively, were achieved for the detection of Barrett’s neoplasia with an area under the curve of 0.95. No adverse events attributed to the heterodimer were found. EGFR and ErbB2 expression were validated in the resected specimens. Conclusions This “first-in-human” clinical study demonstrates the feasibility of detection of early Barrett’s neoplasia using a NIR-labeled peptide heterodimer.

BACKGROUND: COVID-19 pandemic-related disruptions to EUS-based pancreatic cancer surveillance in high-risk individuals remain uncertain. METHODS: Analysis of enrolled participants in the CAPS5 Study, a prospective multicenter study of pancreatic cancer surveillance in high-risk individuals. RESULTS: Amongst 693 enrolled high-risk individuals under active surveillance, 108 (16%) had an EUS scheduled during the COVID-19 pandemic-related shutdown (median length of 78 days) in the spring of 2020, with 97% of these procedures being canceled. Of these canceled surveillance EUSs, 83% were rescheduled in a median of 4.1 months, however 17% were not rescheduled after 6 months follow-up. Prior history of cancer was associated with increased likelihood of rescheduling. To date no pancreatic cancer has been diagnosed among those whose surveillance was delayed. CONCLUSIONS: COVID-19 delayed pancreatic cancer surveillance with no adverse outcomes in efficiently rescheduled individuals. However, 1 in 6 high-risk individuals had not rescheduled surveillance, indicating the need for vigilance to ensure timely surveillance rescheduling.

Squamous cells are rarely found in biliary tract cytology specimens, and when present are typically scant in quantity. Over an 8-year time period, two cases at our institution reporting abundant squamous cells were identified. Both patients underwent endoscopic retrograde cholangiopancreatography with bile duct brushings and removal of a migrated biliary stent. The migrated stents were retrieved using rat toothed forceps and required removal of the endoscope through the esophagus with the stent exposed to esophageal and oral mucosa outside of the endoscope. Cytologic examination of the accompanying biliary stent material accordingly revealed abundant benign squamous cells. However, bile duct brushings showed benign ductal epithelial cells without squamous cells. Prior and subsequent cytology and bile duct surgical pathology specimens did not show squamous metaplasia. Migrated biliary stents that require endoscopic withdrawal increase the risk of contaminating samples with squamous cells. Recognition of this unique scenario is important, as the differential diagnosis includes squamous metaplasia and squamous neoplasia.

Improved methods for early cancer detection arising from Barrett’s oesophagus (BE) are still needed. Imaging molecular expression patterns in BE patients can target neoplasia. We demonstrate a multiplexed fluorescence imaging approach to detect premalignant lesions with two fluorescently labeled heptapeptides specific for EGFR and ErbB2. Twenty-two BE patients underwent endoscopic imaging with a multimodal scanning fiber endoscope (mmSFE). In this pilot study, 92% of neoplastic lesions could be imaged by comparison with pathology, with only 11% false positives. This first-in-human study demonstrates feasibility to concurrently detect multiple targets in vivo and potential for early detection of cancers that are molecularly heterogeneous. ### Background Oesophageal adenocarcinoma (EAC) is a deadly disease that has increased dramatically in incidence over the past several decades.1 2 Endoscopic screening with white light illumination and random biopsy is limited by sampling error.3 Dysplasia often presents with flat architecture and patchy distribution.4 EGFR and ErbB2 are transmembrane tyrosine kinase receptors that stimulate epithelial cell growth, proliferation and differentiation.5 Overexpression of these targets reflects a higher risk for cancer progression.6–8 Multiplexed imaging methods take advantage of the broad spectrum of light over the visible and near-infrared (NIR) regimen. We aim to demonstrate clinical feasibility to visualise EGFR and ErbB2 expression simultaneously in vivo to detect Barrett’s neoplasia. ### Methods Consecutive patients referred for either evaluation or therapy of Barrett’s neoplasia were recruited for the study (NCT03589443). An mmSFE was designed to collect multiplexed fluorescence images concurrently. Target/background (T/B) ratios were calculated for each fluorescence image. More details on the methods and the multiplexed imaging technology can be found in the online supplemental file. ### Supplementary data [gutjnl-2020-322945supp001.pdf] ### Results The peptide QRHKPRE specific for EGFR was labelled with Cy5 via a GGGSK linker, (figure 1A).9 KSPNPRF, specific for ErbB2, was labelled with IRDye800 via a GGGSC linker (figure 1B). …

Summary 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.

Background:Incidence rates of gastric cancer are increasing in young adults (age Methods:We used population-based data from the California and Texas Cancer Registries from 1995 to 2016 to estimate age-adjusted incidence rates of EOGC among Hispanic and non-Hispanic White persons by year, sex, tumor stage, census tract poverty level, metro versus nonmetro county, and state. We used logistic regression models to identify factors associated with distant stage diagnosis.Results:Of 3,047 persons diagnosed with EOGC, 73.2% were Hispanic White. Incidence rates were 1.29 [95% confidence interval (CI), 1.24–1.35] and 0.31 (95% CI, 0.29–0.33) per 100,000 Hispanic White and non-Hispanic White persons, respectively, with consistently higher incidence rates among Hispanic persons at all levels of poverty. There were no statistically significant associations between ethnicity and distant stage diagnosis in adjusted analysis.Conclusions:There are ethnic disparities in EOGC incidence rates that persist across poverty levels.Impact:EOGC incidence rates vary by ethnicity and poverty; these factors should be considered when assessing disease risk and targeting prevention efforts.

Background Pancreatic cancer is projected to become the second leading cause of cancer‐related deaths by 2030. Endoscopic retrograde cholangiopancreatography (ERCP) is recommended as first‐line therapy for biliary decompression in pancreatic cancer. The aim of our study was to characterize geographic and racial/ethnic disparities in ERCP utilization among patients with pancreatic cancer. Methods Retrospective cohort study using the US Surveillance, Epidemiology, and End Results (SEER)‐Medicare database to identify patients diagnosed with pancreatic cancer from 2003‐2013. The primary outcome was receipt of ERCP, with or without stent placement, vs any non‐ERCP biliary intervention. Results Of the 36 619 patients with pancreatic cancer, 37.5% (n = 13 719) underwent an ERCP, percutaneous drainage, or surgical biliary bypass. The most common biliary intervention (82.6%) was ERCP. After adjusting for tumor location and stage, Blacks were significantly less likely to receive ERCP than Whites (aOR 0.84, 95% CI 0.72, 0.97) and more likely to receive percutaneous transhepatic biliary drainage (PTBD) (aOR 1.38, 95% CI 1.14, 1.66). Patients in the Southeast and the West were more likely to receive ERCP than those in the Northeast (Southeast aOR 1.21, 95% CI 1.04, 1.40; West aOR 1.16, 95% CI 1.01, 1.32). Conclusion Racial/ethnic and geographic disparities in access to biliary interventions including ERCP exist for patients with pancreatic cancer in the United States. Our results highlight the need for further research and policies to improve access to appropriate biliary intervention for all patients.

OBJECTIVES: Current standard of care imaging, cytology, or cystic fluid analysis cannot reliably differentiate malignant from benign pancreatic cystic neoplasms. This study sought to determine if the metabolic profile of cystic fluid could distinguish benign and malignant lesions, as well as mucinous and non-mucinous lesions. Methods: Metabolic profiling by untargeted mass spectrometry and quantitative nuclear magnetic resonance was performed in 24 pancreatic cyst fluid from surgically resected samples with pathological diagnoses and clinicopathological correlation. Results: (Iso)-butyrylcarnitine distinguished malignant from benign pancreatic cysts, with a diagnostic accuracy of 89%. (Iso)-butyrylcarnitine was 28-fold more abundant in malignant cyst fluid compared with benign cyst fluid (P=.048). Furthermore, 5-oxoproline (P=.01) differentiated mucinous from non-mucinous cysts with a diagnostic accuracy of 90%, better than glucose (82% accuracy), a previously described metabolite that distinguishes mucinous from non-mucinous cysts. Combined analysis of glucose and 5-oxoproline did not improve the diagnostic accuracy. In comparison, standard of care cyst fluid carcinoembryonic antigen (CEA) and cytology had a diagnostic accuracy of 40% and 60% respectively for mucinous cysts. (Iso)-butyrylcarnitine and 5-oxoproline correlated with cyst fluid CEA levels (P 3 cm, ≥ 1 high-risk features, cyst fluid CEA, and cytology are 38%, 75%, 80%, and 75%, respectively. Conclusions: (Iso)-butyrylcarnitine has potential clinical application for accurately distinguishing malignant from benign pancreatic cysts, and 5-oxoproline for distinguishing mucinous from non-mucinous cysts.

Background: Esophageal adenocarcinoma is a molecularly heterogeneous disease that is rising rapidly in incidence and has a poor prognosis. Current methods of endoscopic surveillance in patients with Barrett’s esophagus (BE) using white light illumination are not sensitive to pre-malignant lesions that are flat in appearance and patchy in distribution. We aim to demonstrate specific binding by a peptide heterodimer to Barrett’s neoplasia in human subjects. Methods: Peptide monomers specific for EGFR and ErbB2 were arranged in a heterodimer configuration and labeled with IRDye800. The near-infrared (NIR)-labeled heterodimer was synthesized using current good manufacturing practices (cGMP) methods and performed pharmacology/toxicology study in animals using good laboratory practices (GLP). The NIR contrast agent was topically administered in the distal esophagus of patients with history of neoplastic BE undergoing endoscopic therapy or surveillance. Fluorescence images were collected using a flexible fiber accessory passed through the instrument channel of an upper endoscope. Fluorescence images were collected from n = 31 BE patients, and a deep learning model was used to segment the target (T) and background (B) regions to calculate the T/B ratio. Findings: Between August 2018 and November 2020, 25 human subjects were enrolled for safety study and 31 patients for either evaluation or therapy of Barrett’s neoplasia were recruited for imaging study. No adverse events attributed to the heterodimer were found. The mean T/B ratio in patients for HGD and EAC were significantly greater than that for BE with low grade dysplasia, without dysplasia, or squamous mucosa. At a T/B ratio of 1.5, 94.1% sensitivity and 92.6% specificity for detection of Barrett’s neoplasia was achieved with an AUC = 0.95. The presence of Barrett’s neoplasia was validated by pathological assessment of resected specimens. Interpretation: This “first-in-human” clinical study demonstrates feasibility to detect early Barrett’s neoplasia using a NIR-labeled peptide heterodimer. Trial Registration: This study was registered online at ClinicalTrials.gov (NCT03643068) Funding National Institutes of Health. Declaration of Interest: Authors (JC, TDW) are inventors on patents filed by the University of Michigan on the peptide heterodimer used in this study. Author (EJS) is an inventor on patents filed by the University of Washington on the multimodal scanning fiber endoscope (mmSFE) used in this study. The other authors disclose no conflicts. Ethical Approval: All study protocols were reviewed and approved by the Institutional Review Board (IRB) at Michigan Medicine

The concept that sphincter of Oddi dysfunction (SOD) can cause attacks of biliary-type pain in postcholecystectomy patients and those with unexplained recurrent acute pancreatitis, and that endoscopic sphincterotomy can ameliorate symptoms, remains unproven. The Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD) study of patients without objective evidence for biliary obstruction showed no difference in outcomes between those who underwent sphincterotomy or sham treatment.1 To date, there have been no studies examining the characteristics of patients who still are being offered endoscopic retrograde cholangiopancreatography (ERCP) for SOD since the EPISOD publication, although the absolute number appears to have declined.2.

Background & Aims The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. Methods Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. Results A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76–1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80–2.12) were not associated independently with mechanical ventilation or death. Conclusions Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.

Background and Aims The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool. Methods Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability. Results Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists’ skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis. Conclusions Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice.

BackgroundThe prevalence and significance of digestive manifestations in COVID-19 remain uncertain.MethodsConsecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were manually abstracted from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19.ResultsA total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least one gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were elevated to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio 0.93, 95% confidence interval 0.76-1.15) or liver test abnormalities on admission (odds ratio 1.31, 95% confidence interval 0.80-2.12) were not independently associated with mechanical ventilation or death.ConclusionsAmong patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common but the majority were mild and their presence was not associated with a more severe clinical course

Most patients with pancreatic cancer are diagnosed at a late stage and are not candidates for surgical resection. Many have jaundice requiring biliary drainage, which can be accomplished using ERCP or percutaneous transhepatic biliary drainage (PTBD). To date, no studies have evaluated the impact of ERCP or PTBD on survival among patients with unresectable pancreatic cancer. The aims of our study were to compare overall survival between patients with unresectable pancreatic cancer receiving ERCP with those receiving PTBD, to compare overall survival between patients who received a biliary intervention (ERCP or PTBD) versus those who received no biliary intervention, and to compare secondary outcomes, such as length of hospital stay and costs, between ERCP and PTBD.We conducted a retrospective cohort study using the Surveillance, Epidemiology, and End Results-Medicare database. Patients with known pancreatic cancer were included if they had a pancreatic head mass and/or evidence of biliary obstruction. We used a time-varying Cox proportional hazards model to estimate overall survival of patients receiving ERCP versus PTBD and overall survival among patients who received a biliary intervention versus no biliary drainage. Secondary outcomes included length of hospital stay, costs, and admissions within 30 days.Of 14,808 patients with unresectable pancreatic cancer, 8898 patients (60.0%) underwent biliary drainage and 5910 patients (39.9%) received no biliary intervention. ERCP accounted for most biliary interventions (8271, 93.0%), whereas 623 patients (7.0%) underwent PTBD. In multivariable analysis, ERCP was associated with reduced mortality compared with PTBD (adjusted hazard ratio [aHR], .67; 95% confidence interval [CI], .60-.75). When ERCP or PTBD was compared with no biliary intervention, both procedures were associated with a survival benefit (aHR, .51 [95% CI, .49-.54] and .53 [95% CI, .48-.59], respectively). Compared with patients receiving PTBD, those who underwent ERCP had shorter mean length of hospital stay (7.0 ± 5.7 days vs 9.6 ± 6.6 days, respectively; P .001) and lower hospital charges ($54,899.25 vs $75,246.00, P .001) but no significant difference in hospitalization or 30-day readmissions.ERCP is associated with reduced mortality compared with PTBD in pancreatic cancer patients, highlighting the critical role of ERCP in the management of biliary obstruction from pancreatic cancer.

INTRODUCTION: Endoscopic therapy (ET) and esophagectomy result in similar survival for Barrett’s esophagus (BE) with high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC), but the long-term quality of life (QOL) has not been compared. AIMS: We aimed to compare long-term QOL between patients who had undergone ET versus esophagectomy. METHODS: Patients were included if they underwent ET or esophagectomy at the University of Michigan since 2000 for the treatment of HGD or T1a EAC. Two validated survey QOL questionnaires were mailed to the patients. We compared QOL between and within groups (ET = 91, esophagectomy = 62), adjusting for covariates. RESULTS: The median time since initial intervention was 6.8 years. Compared to esophagectomy, ET patients tended to be older, had a lower prevalence of EAC, and had a shorter duration since therapy. ET patients had worse adjusted physical and role functioning than esophagectomy patients. However, the adjusted odds ratio (OR) of having symptoms was significantly less with ET for diarrhea (0.287; 95% confidence interval [CI] = 0.114, 0.724), trouble eating (0.207; 0.0766, 0.562), choking (0.325; 0.119, 0.888), coughing (0.291; 0.114, 0.746), and speech difficulty (0.306; 0.0959, 0.978). Amongst the ET patients, we found that the number of therapy sessions and need for dilation were associated with worse outcomes. DISCUSSION: Multiple measures of symptom status were better with ET compared to esophagectomy following treatment of BE with HGD or T1a EAC. We observed worse long-term physical and role functioning in ET patients which could reflect unmeasured baseline functional status rather than a causal effect of ET.

Background and Aims EMR is the preferred endoscopic therapy for duodenal adenomas (DAs) but is associated with an overall adverse event rate of 26%. Cryotherapy using a Cryoballoon Focal Ablation System (CbFAS) can safely and effectively eradicate esophageal intestinal metaplasia. We report our first experience with cryoballoon ablation for treatment of flat DAs. Methods This was an American, multicenter, retrospective study involving 5 centers. DAs (Paris 0-IIa and 0-IIb) were treated with nitrous oxide for 5 to 12 seconds using CbFAS. Follow-up EGD was performed at 3 to 12 months. Results Seventeen DAs (mean size, 22.7 ± 14.3 mm; 12 tubular, 5 tubulovillous) from 13 patients (mean age, 66.5 ± 9.99 years; 61.5% males) were included in the study. Thirteen of 17 DAs (76.5%) had failed previous treatment, and 4 of 17 (23.5%) were treatment naIve. All procedures were technically successful and achieved a >50% decrease in size after cryoballoon ablation There was no increase in size or progression of disease for any lesions. Overall, treatment was completed in 15 of 17 patients, and recurrence-free survival was achieved in 12 of 17 (71%) after a median follow-up of 15.5 months (interquartile range [IQR], 6.8-19.4). The median cryoablation time per polyp was 4 minutes (IQR, 1-7.5 minutes), and the median total procedure time was 25 minutes (IQR, 22-30.5 minutes). There were no intra- or postprocedural adverse events. Conclusions Nitrous oxide cryoballoon ablation of nonpolypoid DAs is feasible, with promising safety and efficacy.

This clinical guideline from the American Society for Gastrointestinal Endoscopy (ASGE) provides an evidence-based approach for the management of patients with malignant hilar obstruction (MHO). This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework and addresses primary drainage modality (percutaneous transhepatic biliary drainage [PTBD] vs endoscopic biliary drainage [EBD]), drainage strategy (unilateral vs bilateral), and stent selection (plastic stent [PS] vs self-expandable metal stent [SEMS]). Regarding drainage modality, in patients with MHO undergoing drainage before potential resection or transplantation, the panel suggests against routine use of PTBD as first-line therapy compared with EBD. In patients with unresectable MHO undergoing palliative drainage, the panel suggests PTBD or EBD. The final decision should be based on patient preferences, disease characteristics, and local expertise. Regarding drainage strategy, in patients with unresectable MHO undergoing palliative stent placement, the panel suggests placement of bilateral stents compared with a unilateral stent in the absence of liver atrophy. Finally, regarding type of stent, in patients with unresectable MHO undergoing palliative stent placement, the panel suggests placing SEMSs or PSs. However, in patients who have a short life expectancy and who place high value on avoiding repeated interventions, the panel suggests using SEMSs compared with PSs. If optimal drainage strategy has not been established, the panel suggests placing PSs. This document clearly outlines the process, analyses, and decision processes used to reach the final recommendations and represents the official ASGE recommendations on the above topics.

Cholangitis is a GI emergency requiring prompt recognition and treatment. The purpose of this document from the American Society for Gastrointestinal Endoscopy's (ASGE) Standards of Practice Committee is to provide an evidence-based approach for management of cholangitis. This document addresses the modality of drainage (endoscopic vs percutaneous), timing of intervention ( 48 hours), and extent of initial intervention (comprehensive therapy vs decompression alone). Grading of Recommendations, Assessment, Development, and Evaluation methodology was used to formulate recommendations on these topics. The ASGE suggests endoscopic rather than percutaneous drainage and biliary decompression within 48 hours. Additionally, the panel suggests that sphincterotomy and stone removal be combined with drainage rather than decompression alone, unless patients are too unstable to tolerate more extensive endoscopic treatment.

Hilar biliary strictures present a unique challenge to endoscopists because of the difficulty in securing a diagnosis for the stricture and providing adequate therapeutic drainage. Hilar strictures can be secondary to underlying liver disease, such as primary sclerosing cholangitis (PSC), or postsurgical complications. However, the majority of hilar strictures are concerning for underlying malignancy such as cholangiocarcinoma. The challenge in diagnosing cholangiocarcinoma lies in part due to its desmoplastic character and tropism for bile such that it extends along the duct rather than grow intraluminally. Endoscopic retrograde cholangiopancreatography (ERCP) plays a critical role in the diagnosis of hilar strictures through the use of cytology brushings, biopsy forceps, and cholangioscopy and may require several procedures to secure a diagnosis. Therapeutic management of these strictures is also complex since endoscopists have to decide between unilateral versus bilateral biliary drainage, plastic or self-expandable metal stent (SEMS) placement, and, if bilateral SEMS is pursued, the ideal configuration for the SEMS. The goal of this chapter is to help present current data and our own personal approach to the diagnosis and therapeutic management of hilar strictures.

This American Society for Gastrointestinal Endoscopy guideline provides evidence-based recommendations for the endoscopic management of gastric outlet obstruction (GOO). We applied the Grading of Recommendations, Assessment, Development and Evaluation methodology to address key clinical questions. These include the comparison of (1) surgical gastrojejunostomy to the placement of self-expandable metallic stents (SEMS) for malignant GOO, (2) covered versus uncovered SEMS for malignant GOO, and (3) endoscopic and surgical interventions for the management of benign GOO. Recommendations provided in this document were founded on the certainty of the evidence, balance of benefits and harms, considerations of patient and caregiver preferences, resource utilization, and cost-effectiveness.

Esophageal fully covered self-expandable metal stents (FCSEMS) are indicated for the management of benign and malignant conditions of the esophagus including perforations, leaks, and strictures. FCSEMS are resistant to tissue ingrowth and are removable; however, stent migration occurs in 30-55% of cases. Endoscopic suture fixation of FCSEMS has been utilized to decrease the risk of stent migration though data supporting this practice remain limited. The primary aim of this study was to compare clinical outcomes and migration rate of patients who underwent placement of esophageal FCSEMS with and without endoscopic suture fixation.Our single-center, retrospective, cohort study includes patients who underwent esophageal FCSEMS placement with and without endoscopic suture fixation between January 1, 2012, and November 11, 2015. Baseline patient characteristics, procedural details, and clinical outcomes were abstracted. Logistic regression was performed to identify clinical and technical factors associated with outcomes and stent migration.A total of 51 patients underwent 62 FCSEMS placements, including 21 procedures with endoscopic suture fixation and 41 without. Suture fixation was associated with reduced risk of stent migration (OR 0.13, 95% CI 0.03-0.47). Prior stent migration was associated with significantly higher risk of subsequent migration (OR 6.4, 95% CI 1.6-26.0). Stent migration was associated with lower likelihood of clinical success (OR 0.21, 95% CI 0.06-0.69). There was a trend toward higher clinical success among patients undergoing suture fixation (85.7 vs. 60.9%, p = 0.07).Endoscopic suture fixation of FCSEMS was associated with a reduced stent migration rate. Appropriate patient selection for suture fixation of FCSEMS may lead to reduced migration in high-risk patients.

Background and Aims The need for transpapillary drainage (TPD) in patients undergoing transmural drainage (TMD) of pancreatic fluid collections (PFCs) remains unclear. The aims of this study were to compare treatment outcomes between patients with pancreatic pseudocysts undergoing TMD versus combined (TMD and TPD) drainage (CD) and to identify predictors of symptomatic and radiologic resolution. Methods This is a retrospective review of 375 consecutive patients with PFCs who underwent EUS-guided TMD from 2008 to 2014 at 15 academic centers in the United States. Main outcome measures included TMD and CD technical success, treatment outcomes (symptomatic and radiologic resolution) at follow-up, and predictors of treatment outcomes on logistic regression. Results A total of 375 patients underwent EUS-guided TMD of PFCs, of which 174 were pseudocysts. TMD alone was performed in 95 (55%) and CD in 79 (45%) pseudocysts. Technical success was as follows: TMD, 92 (97%) versus CD, 35 (44%) ( P = .0001). There was no difference in adverse events between the TMD (15%) and CD (14%) cohorts ( P = .23). Median long-term (LT) follow-up after transmural stent removal was 324 days (interquartile range, 72-493 days) for TMD and 201 days (interquartile range, 150-493 days) ( P = .37). There was no difference in LT symptomatic resolution (TMD, 69% vs CD, 62%; P = .61) or LT radiologic resolution (TMD, 71% vs CD, 67%; P = .79). TPD attempt was negatively associated with LT radiologic resolution of pseudocyst (odds ratio, 0.11; 95% confidence interval, 0.02-0.8; P = .03). Conclusions TPD has no benefit on treatment outcomes in patients undergoing EUS-guided TMD of pancreatic pseudocysts and negatively affects LT resolution of PFCs.