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

University of California Irvine (UCI)

Status: Not yet enrolling

Conditions: Achalasia, Esophageal; GERD (Gastroesophageal Reflux Disease)

Treatments: Procedure: Conventional POEM; Procedure: Sling Fiber-Preserving POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT07178821

7028 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Achalasia is a rare esophageal motility disorder treated effectively with peroral endoscopic myotomy (POEM). However, post-procedure gastroesophageal reflux disease (GERD) is a common complication, reported in up to 65% of cases. One proposed technical modification - the selective preservation of gastric sling fibers - may help reduce reflux by maintaining part of the native anti-reflux mechanism.

This is a single-blinded, multicenter randomized controlled trial comparing sling fiber preservation (SFP) POEM versus conventional POEM in adult patients with achalasia. Patients are randomized 1:1 to either technique. The primary endpoint is the incidence of significant reflux esophagitis (LA esophagitis grade B or higher) at 3 months post-procedure endoscopy. Secondary outcomes include acid exposure time on pH impedence monitoring, symptomatic reflux (GerdQ), PPI usage, technical and clinical success, and adverse events. Follow-up continues for 12 months.

The study aims to determine whether the SFP-POEM technique reduces acid reflux without compromising treatment efficacy.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Participants must meet all of the following):

• Age ≥ 18 years
• Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0
• Deemed appropriate candidates for POEM
• Ability to provide informed consent

Exclusion Criteria (Participants will be excluded if any of the following apply):

• 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
• Pregnancy or actively breastfeeding
• Significant cardiopulmonary comorbidities that preclude safe endoscopic intervention
• Coagulopathy or portal hypertension
• Unwillingness or inability to complete follow-up assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Conventional POEM

Active Comparator group

Description:

Participants in this arm will undergo standard peroral endoscopic myotomy (POEM), including myotomy of circular and sling muscle fibers at the gastric side.

Treatment:

Procedure: Conventional POEM

Sling Fiber-Preservation POEM

Experimental group

Description:

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.

Treatment:

Procedure: Sling Fiber-Preserving POEM