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

Not Applicable

Not yet recruiting

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)	3 months post-procedure	Reflux esophagitis will be assessed by upper endoscopy (EGD) at 3 months post-POEM. Grading will be based on the Los Angeles (LA) Classification. Significant reflux is defined as LA Grade B or higher.

Secondary Outcome Measures

Name	Time	Method
Esophageal Acid Exposure	3 months post-procedure	Measured by 24-hour Bravo pH monitoring off PPIs for ≥2 weeks. Pathologic reflux is defined as acid exposure time \>6% and/or DeMeester score \>14.72.
Symptomatic Gastroesophageal Reflux (GerdQ Score)	3, 6, 12 months post-procedure	Symptom-based GERD assessment using the GerdQ questionnaire. A score \>7 indicates clinically significant symptoms.
Proton Pump Inhibitor (PPI) Use	3, 6, 12 months post-procedure	Assessment of ongoing PPI therapy and symptom-guided discontinuation based on reflux control.
Clinical Success (Eckardt Score ≤ 3)	3, 6 and 12 months post-procedure	Symptom improvement measured using the Eckardt score. A score ≤ 3 is considered successful clinical outcome.
Technical Success	Day of procedure	Technical success defined as completion of full-length myotomy as planned.
Adverse Events	Within 1 month post-procedure	Monitoring of intra- and post-procedural complications, including bleeding, perforation, capno-peritoneum, leak, infection, and other unexpected events.

Locations (1): University of California, Irvine - UCI Medical Center
🇺🇸
Orange, California, United States
University of California, Irvine - UCI Medical Center
🇺🇸Orange, California, United States
Frances Dang, MD
Sub Investigator
Jason Samarasena, MD, MBA
Principal Investigator