Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07178821
NA

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

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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.

Official title: Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD: A Randomized Control Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-12-01

Completion Date

2028-01-01

Last Updated

2025-10-22

Healthy Volunteers

No

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.

Locations (1)

University of California, Irvine - UCI Medical Center

Orange, California, United States