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

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.

Conditions

• Achalasia, Esophageal
• GERD (Gastroesophageal Reflux Disease)

Interventions

PROCEDURE

Conventional POEM

Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.

PROCEDURE

Sling Fiber-Preserving POEM

Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian

  collaborator OTHER

• University of Ottawa

  collaborator OTHER

• Vancouver General Hospital

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• University of California, Irvine

  lead OTHER

Principal Investigators

• Jason Samarasena, MD, MBA · University of California, Irvine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2027-12-01

Completion

2028-01-01

Countries

• United States

Study Locations