Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

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

120 Participants
are divided into 2 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