Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure: A Pilot Study
Christopher C. Thompson, MD, MSc
Summary
Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The Pylorus Sparing Antral Myotomy (PSAM) technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body. PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability (GCSI score) or the safety profile of the procedure (2 DDW GEM abstracts). PSAM has not been evaluated alone, without concomitant ESG. Since delayed gastric emptying alone is known to promote weight loss, it is thought that PSAM alone (without ESG) may provide similar efficacy, while reducing procedure time and adverse events. There have been no clinical studies that investigate the efficacy of PSAM independent of ESG. This pilot study aims to address this lack of information by evaluating the safety, tolerability, and short-term efficacy of PSAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial.
Description
Obesity, defined as body mass index (BMI) greater than 30 kg/m2 in adults, is affecting 30% of the global population and a significant healthcare burden. \[1\] Obesity has increased dramatically over the last few decades, with over 650 million adults, or 13% of the world's total adult population, diagnosed with the disease in 2016 - a figure that has nearly tripled since 1975.\[1\] In the U.S the obesity prevalence for U.S. adults increased from 14.1% to 26.7%, or an 89.9% increase between 1993 and 2008.\[1,2,3\] As a result, current and potential interventions, and treatment strategies to com…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * subjects must be 18-70 years of age * eligible for endoscopic and surgical weight loss procedures * body mass index (BMI) greater than 35 kg/m2 * Individuals must be in excellent mental health * able to understand and sign informed consent * available to return for all routine follow-up study visits Exclusion Criteria: * untreated H. pylori infection * gastroparesis * active smoking * an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment * previous pyloromyotomy or pyloroplasty * gastrointestinal obstruction * severe coagulopathy *…
Interventions
- ProcedurePSAM Treatment Patients
PSAM is a pylorus-sparing antral myotomy performed under general anesthesia. Endoscopic myotomy is then performed applying the principles of submucosal endoscopy and techniques used during gastric per-oral endoscopic myotomy (G-POEM). A submucosal bleb is created proximal to the pylorus. A longitudinal mucosal incision is made with an endoscopic knife. The endoscope is then introduced into the submucosal space, and the knife is used to dissect the submucosal fibers. Antral myotomy is performed starting proximal to the pyloric ring extending to the mucosal access site. The myotomy entails cutting of the inner circular and oblique muscle bundles or may be full thickness at the discretion of the endoscopist. The mucosal entry is then closed using endoscopic suturing or clips.
Location
- Brigham and Women's HospitalBoston, Massachusetts