Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD: A Randomized Control Trial
University of California, Irvine
Summary
Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.
Description
Achalasia is a rare esophageal motility disorder treated effectively with peroral endoscopic myotomy (POEM). However, post-procedure gastroesophageal reflux disease (GERD) is a common complication, reported in up to 65% of cases. One proposed technical modification - the selective preservation of gastric sling fibers - may help reduce reflux by maintaining part of the native anti-reflux mechanism. This is a single-blinded, multicenter randomized controlled trial comparing sling fiber preservation (SFP) POEM versus conventional POEM in adult patients with achalasia. Patients are randomized 1:1…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (Participants must meet all of the following): * Age ≥ 18 years * Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0 * Deemed appropriate candidates for POEM * Ability to provide informed consent Exclusion Criteria (Participants will be excluded if any of the following apply): * Spastic motility disorders other than achalasia type I-III (e.g. diffuse esophageal spasm, jackhammer esophagus, EGJ outflow obstruction) * Sigmoid esophagus * Prior surgical myotomy (e.g., Heller myotomy) * Contraindications to endoscopy or general anesthesia * Pregnancy or activ…
Interventions
- ProcedureConventional POEM
Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.
- ProcedureSling Fiber-Preserving POEM
Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.
Location
- University of California, Irvine - UCI Medical CenterOrange, California