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Introduction: Rectal indomethacin and topical spray of epinephrine have separately shown efficacy in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) in randomized controlled trials. We hypothesized that the combination of indomethacin and topical spray of epinephrine on the duodenal papillae would further reduce PEP than when indomethacin was used alone., Methods: We conducted a comparative effectiveness, multicenter, double-blinded, randomized trial of rectal indomethacin alone vs a combination of rectal indomethacin and topical spray of epinephrine for the prevention of PEP in high-risk patients. The primary outcome was the incidence of PEP and the secondary outcome was the severity of PEP. A 2-tailed Fisher's exact test was used to analyze the difference in the proportion of patients with PEP in the indomethacin alone vs the combination group., Results: A total of 960 patients (mean age 52.33 ± 14.96 years; 551 [57.4%] females) were randomized and 959 completed follow-up. The baseline demographic and clinical characteristics were similar between the 2 groups. Women <50 years of age (25.4%) and difficult cannulation (84.9%) were the most common PEP risk factors. The incidence of PEP was 6.4% in the indomethacin alone group (n = 482) compared to 6.7% in the combination group (n = 477; P = 0.87). Severe PEP was found in 5 (12%) and 7 (16%) patients in the indomethacin alone and combination groups, respectively (P = 0.88). The overall mortality was 0.6%, which was unrelated to the primary outcome., Conclusions: The combination of rectal indomethacin and topical spray of epinephrine does not reduce the incidence of PEP compared to rectal indomethacin alone in high-risk patients; https://clinicaltrials.gov/ct2/show/NCT02116309.

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.

There is a desperate need for a technically simple, reversible, clinically effective, and safe approach to facilitate weight loss and improvement in metabolic comorbidities in obese patients. This has led to significant investment into the development of endoscopic bariatric therapies. In this issue of the American Journal of Gastroenterology, the first randomized controlled trial assessing aspiration therapy using an endoscopically placed gastrostomy tube is reported with promising results. Aspiration therapy is the first endoscopic therapy to be approved in the United States for use in morbidly obese patients and may be an alternative to those not wishing to undergo bariatric surgery.

Objectives: There is no consensus on how best to treat symptom recurrence following previous therapy with Heller myotomy. Our aim was to determine the safety and the short and long-term efficacy of pneumatic dilatation to treat symptomatic recurrence in patients previously treated with Heller myotomy for idiopathic achalasia., Methods: We identified 27 eligible patients treated with pneumatic dilatation, for symptom recurrence following Heller myotomy as their initial or secondary treatment, from a prospectively acquired database of 450 patients with a diagnosis of achalasia seen between 1995 and 2010. Our treatment protocol involved sequential, graded pneumatic dilatations (30-35-40 mm) over a 2-6 week period until an initial therapeutic response was achieved. The subsequent relapse rate, defined as the need for any subsequent therapy, was determined. Relapsers were offered further pneumatic dilatation "on demand". A cross-sectional analysis was also performed using a validated achalasia severity questionnaire to determine the overall long-term remission rate., Results: Of 27 eligible patients, 25 (93%) complied with the institutional dilatation protocol. The two drop-outs did so after the initial 30 mm dilatation and were deemed treatment failures. One additional patient did not respond despite protocol compliance. Therefore, 24 of 27 (89%) patients were responders on intention to treat analysis at 12 months, while the per protocol response rate was 24 of 25 (96%). Among the 24 responders 16, 25, and 42% relapsed at 2, 3 and 4  years, respectively. Overall long-term remission, with on demand dilatations as required, was 95% (median follow-up 30 months). There were no perforations in a total of 50 dilatations in 27 patients., Conclusions: In treating symptom recurrence, following prior Heller myotomy, pneumatic dilatation is safe and yields an excellent short-term response rate. Although the long-term relapse rate is substantial, subsequent on demand pneumatic dilatation in this population is highly effective with a long-term remission rate of 95%. These data also highlight the need to keep these patients under long-term review.