An interventional study of Conventional POEM and Sling Fiber-Preserving POEM in Achalasia, Esophageal and GERD (Gastroesophageal Reflux Disease), sponsored by University of California, Irvine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
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.
Inclusion Criteria (Participants must meet all of the following):
Exclusion Criteria (Participants will be excluded if any of the following apply):
Participants in this arm will undergo standard peroral endoscopic myotomy (POEM), including myotomy of circular and sling muscle fibers at the gastric side.
Procedure: Conventional 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.
Procedure: Sling Fiber-Preserving POEM
Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.
Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.
Also known as: SFP-POEM
Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)
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.
Time frame: 3 months post-procedure
Esophageal Acid Exposure
Esophageal acid exposure will be measured by 24-hour Bravo pH monitoring performed off PPIs for at least 2 weeks. Reflux severity is quantified using acid exposure time (%) and the DeMeester composite score. The DeMeester score has no fixed maximum; higher values indicate greater esophageal acid exposure. Pathologic reflux is defined as acid exposure time \>6% and/or a DeMeester score \>14.72.
Time frame: 3 months post-procedure
Symptomatic Gastroesophageal Reflux (GerdQ Score)
Symptom-based GERD assessment will be measured using the Gastroesophageal Reflux Disease Questionnaire (GerdQ), which ranges from 0 to 18. Higher scores indicate more frequent or severe reflux symptoms, while lower scores indicate fewer or no symptoms. A score \>7 is considered clinically significant.
Time frame: 3, 6, 12 months post-procedure
Proton Pump Inhibitor (PPI) Use
Assessment of ongoing PPI therapy and symptom-guided discontinuation based on reflux control.
Time frame: 3, 6, 12 months post-procedure
Clinical Success (Eckardt Symptom Score ≤ 3)
Symptom improvement will be measured using the Eckardt Symptom Score, which ranges from 0 to 12. Higher scores indicate more severe symptoms (dysphagia, chest pain, regurgitation, and weight loss), while lower scores indicate symptom improvement. A score ≤ 3 is considered a successful clinical outcome.
Time frame: 3, 6 and 12 months post-procedure
Technical Success
Technical success defined as completion of full-length myotomy as planned.
Time frame: During procedure
Adverse Events
Monitoring of intra- and post-procedural complications, including bleeding, perforation, capno-peritoneum, leak, infection, and other unexpected events.
Time frame: Within 1 month post-procedure
Plan to share: No — Individual participant data (IPD) will not be shared outside the study team. The current protocol does not include provisions for public or external data sharing.
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University of California, Irvine