About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0
Deemed appropriate candidates for POEM
Ability to provide informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- Conventional POEM
- Sling Fiber-Preserving POEM
Treatment groups
Sponsors and collaborators
University of California, Irvine
Lead sponsor
Hoag Memorial Hospital Presbyterian
Collaborator
University of Ottawa
Collaborator
Vancouver General Hospital
Collaborator
Cedars-Sinai Medical Center
Collaborator