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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT07178821
Status
Not Yet Recruiting

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Conditions

  • Achalasia, Esophageal
  • GERD (Gastroesophageal Reflux Disease)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional POEM — PROCEDURE
    Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.
  • Sling Fiber-Preserving POEM — PROCEDURE
    Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Oct 2025
Primary completion
Dec 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional POEM
    Participants in this arm will undergo standard peroral endoscopic myotomy (POEM), including myotomy of circular and sling muscle fibers at the gastric side.
  • Experimental: Sling Fiber-Preservation POEM
    Participants in this arm will undergo posterior POEM with selective preservation of the gastric sling fibers. Myotomy is performed to the right of the second penetrating vessel to spare the sling fibers. The double scope technique will be employed to confirm that the tunnel ends on the lesser curve, which confirms sparing of the sling fibers.

Primary Outcome Measure

Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher) [ Time Frame: 3 months post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Irvine - UCI Medical CenterOrangeCalifornia92868
Frances Dang, MD
[email protected]
714-456-7447
Jason Samarasena, MD, MBA (PRINCIPAL_INVESTIGATOR)
Frances Dang, MD (SUB_INVESTIGATOR)

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By research site
University of California, Irvine - UCI Medical Center· Orange, CA

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