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Competing Interests: Dr. Chen is a consultant for Boston Scientific. Dr. Valenti is a previous speaker for Boston Scientific and Cook Medical. Dr. Barkun has served as a consultant for Cook Inc., Pendopharm Inc., and Olympus. He has also received research support and served on an advisory committee for Olympus, and has received funds from Cook Inc., Pendopharm Inc.

Background: Management options for marginal ulcers (MU) vary from medical therapy to revision surgery. Medical therapy is often ineffective and revision surgery is associated with a high morbidity and possible recurrence., Aims: To evaluate technical feasibility, efficacy, and safety of endoscopic management of MU by covering the ulcer bed using oversewing and/or deploying a fully covered self-expandable metallic stent (FCSEMS)., Methods: Medical records of consecutive patients who underwent endoscopic suturing and/or FCSEMS deployment for recalcitrant MU between August 2016 and June 2017 at a single academic center were reviewed. Recalcitrant MU was defined as an ulcer that persists after 6 to 8 weeks despite maximal medical therapy (open capsule PPI, 40 mg bid as well as sucralfate qid), cessation of smoking and nonsteroidal anti-inflammatory drugs (NSAIDs), and Helicobacter pylori eradication., Results: Eleven patients (age range 31-60; all females) with mean BMI of 27.72 ± 5.93 kg/m 2 underwent endoscopic suturing and/or stent deployment for recalcitrant MU with abdominal pain at a median of 50 months (range 3-120) post-Roux-en-Y gastric bypass (RYGB). Seven patients were managed by oversewing, two were managed by FCSEMS, and two patients required both. Technical success was 100%. All patients reported resolution of abdominal pain at 1 week. Surveillance endoscopy performed in 10/11 (90.9%) patients at 8 weeks revealed complete ulcer healing in 9/10 (90%). No adverse events were reported., Conclusion: Endoscopic management is an effective and safe method to treat MU and should be considered an alternative to surgical revision. It appears effective for perforated and recalcitrant MU.

Background & Aims: In patients with persistent symptoms after Heller myotomy (HM), treatment options include repeat HM, pneumatic dilation, or peroral endoscopic myotomy (POEM). We evaluated the efficacy and safety of POEM in patients with achalasia with prior HM vs without prior HM., Methods: We conducted a retrospective cohort study of 180 patients with achalasia who underwent POEM at 13 tertiary centers worldwide, from December 2009 through September 2015. Patients were divided into 2 groups: those with prior HM (HM group, exposure; n = 90) and those without prior HM (non-HM group; n = 90). Clinical response was defined by a decrease in Eckardt scores to 3 or less. Adverse events were graded according to criteria set by the American Society for Gastrointestinal Endoscopy. Technical success, clinical success, and rates of adverse events were compared between groups. Patients were followed up for a median of 8.5 months., Results: POEM was technically successful in 98% of patients in the HM group and in 100% of patients in the non-HM group (P = .49). A significantly lower proportion of patients in the HM group had a clinical response to POEM (81%) than in the non-HM group (94%; P = .01). There were no significant differences in rates of adverse events between the groups (8% in the HM group vs 13% in the non-HM group; P = .23). Symptomatic reflux and reflux esophagitis after POEM were comparable between groups., Conclusions: POEM is safe and effective for patients with achalasia who were not treated successfully by prior HM. Although the rate of clinical success in patients with prior HM is lower than in those without prior HM, the safety profile of POEM is comparable between groups., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Objectives: The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM., Methods: Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case-control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders)., Results: A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs., Conclusions: This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.

Background: Marginal ulceration post Roux-en-Y gastric bypass (RYGB) with associated bleeding, although infrequently encountered, can be challenging to treat. Flexible endoscopic therapy is preferred over surgery due to its minimally invasive nature. Bleeding ulcers have traditionally been treated endoscopically by injecting epinephrine, bipolar hemostasis, or clips. Here, we describe our treatment with endoscopic suturing for a massively bleeding marginal ulcer after RYGB., Methods: A 56-year-old female 10 days post RYGB underwent her fourth endoscopy for investigation and management of hematemesis and was found to have a large bleeding anastomotic ulcer. A Rothnet was utilized to remove large blood clots which obstructed endoscopic visualization. Two marginal ulcers were noted, and these were successfully oversewn with endoscopic suturing. The multimedia video (7 min) demonstrates the management of massively bleeding marginal ulcer after RYGB by endoscopic suturing., Results: Patient had no further bleeding and tolerated diet the subsequent day. She was discharged home with no further episodes of hematemesis, and follow-up at 6 weeks showed well-healed ulcer on endoscopy., Conclusion: Endoscopic suturing of a bleeding marginal ulcer appears technically feasible and safe. It should be considered in the treatment algorithm prior to emergency surgery.

Background and Aims: Spastic esophageal disorders (SEDs) include spastic achalasia (type III), diffuse esophageal spasm (DES), and nutcracker/jackhammer esophagus (JH). Per-oral endoscopic myotomy (POEM) has demonstrated efficacy and safety in the treatment of achalasia. Recently, POEM has been indicated for the treatment of SEDs. We conducted a systematic review and meta-analysis to determine the clinical success and safety of POEM in SEDs.Methods: We searched several databases from 01/01/2007 to 01/10/2016 to identify studies (with five or more patients) on POEM for the treatment of SEDs. Weighted pooled rates (WPRs) for clinical success and adverse events (AEs) were calculated for all SEDs. Clinical success was defined as Eckardt scores of ≤3 and/or improvement in severity of dysphagia based on achalasia disease-specific health-related quality of life questionnaire. The WPRs for clinical success and AEs were analyzed using fixed- or random-effects model based on heterogeneity. The proportionate difference in clinical success and post-procedure adverse event rates among individual types of SEDs was also calculated.Results: A total of eight observational studies with 179 patients were included in the final analysis. Two studies were of good quality and six were of fair quality based on the National Institutes of Health quality assessment tool. The WPR with 95% confidence interval (CI) for cumulative clinical success of POEM in all SEDs was 87% (78, 93%), I 2 = 37%. The total number of patients for individual disorders, i.e., type III achalasia, JH, and DES, was 116, 37, and 18, respectively. The WPRs for clinical success of POEM for type III achalasia, DES, and JH were 92, 88, and 72%, respectively. Proportion difference of WPR for clinical success was significantly higher for type III achalasia in comparison with JH (20%, P = 0.01). The WPR with 95% CI for AEs of POEM in all SEDs was 14% (9, 20%), I 2 = 0%. The WPRs for post-procedure adverse events for type III achalasia, DES, and JH were 11, 14, and 16%, respectively. There was no difference in safety of POEM among individual SEDs.Conclusion: POEM is an effective and safe therapeutic modality for the treatment of spastic esophageal disorders. [ABSTRACT FROM AUTHOR]

Background& Aims: Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction.Methods: The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events.Discussion: The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design.Trial Registration: Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019. [ABSTRACT FROM AUTHOR]