Per-oral Endoscopic Myotomy With Fundoplication for Achalasia - an International Multicenter Randomized Controlled Trial

What this Trial Is About

Achalasia is a common esophageal disorder characterized by failure of the lower esophageal sphincter to relax and absence of esophageal peristalsis, causing symptoms like difficulty swallowing, chest pain, and regurgitation. Researchers are investigating per-oral endoscopic myotomy with fundoplication (POEM-F) compared to conventional POEM as treatments for achalasia. This international multicenter randomized controlled trial aims to evaluate if POEM-F reduces the rate of gastroesophageal reflux disease (GERD) after treatment, a common complication seen in up to 50-60% of patients undergoing POEM. The study randomly assigns adult patients with manometry-confirmed achalasia to one of two groups: POEM-F or conventional POEM. In POEM-F, after the myotomy, an endoscopic fundoplication is performed mimicking surgical partial fundoplication to reduce GERD risk. Conventional POEM involves an anterior myotomy without fundoplication. Procedures are carried out by experts under general anesthesia. POEM-F includes additional steps such as creating a serosal incision and anchoring the gastric fundus to the esophagogastric junction using clips and an endoloop. Participants will be followed for one year to assess the rate of post-procedure GERD as the primary outcome. Additional assessments include procedure success, adverse events, endoscopic and manometry findings, and symptom questionnaires. The study involves baseline and follow-up evaluations including endoscopies and symptom scores. The goal is to provide evidence on the safety and effectiveness of POEM-F in reducing GERD and improving treatment outcomes for achalasia.

POEM-F for Achalasia International Study