Clinical Research Directory

POEM Versus Laparoscopic Heller Myotomy With Dor Fundoplication for Esophageal Achalasia

Sponsor: Minia University

Summary

Achalasia is a disorder of the esophagus in which the muscular valve between the esophagus and the stomach fails to relax, and the body of the esophagus loses its normal coordinated squeezing movement. People with achalasia have difficulty swallowing both solids and liquids, bring up undigested food, may have chest pain, and often lose weight. None of the available treatments cures the disease; all of them work by reducing the resistance at the junction between the esophagus and the stomach so that food and liquid can pass more easily. Two established treatments do this by cutting the muscle of the valve (a myotomy). Laparoscopic Heller myotomy with a Dor anterior partial fundoplication (LHM + Dor) is performed through small abdominal incisions and includes a wrap of the stomach designed to limit acid reflux afterwards. Peroral endoscopic myotomy (POEM) achieves the same muscle division from inside the esophagus through a tunnel created under the lining, with no skin incisions and no anti-reflux wrap. POEM allows a longer, tailored myotomy, which may be an advantage in the spastic (type III) form of the disease, but reflux after the procedure is more common because no wrap is performed. This trial will randomly assign 220 adults with newly diagnosed, previously untreated achalasia, in equal numbers, to receive either POEM or LHM + Dor. Randomization will be stratified by achalasia subtype (Chicago Classification type I or II versus type III). The main question is whether POEM controls symptoms about as well as LHM + Dor, so the trial is designed as a non-inferiority study with a pre-specified margin of 12.5 percentage points. The primary outcome is clinical success at 12 months, defined as an Eckardt symptom score of 3 or less without any further treatment for achalasia. Participants will be assessed before treatment and again at 30 days and at 3, 6 and 12 months. Assessments include the Eckardt symptom score, reflux symptoms and quality of life, upper endoscopy, high-resolution manometry, timed barium esophagram and, at 3 months, 24-hour pH-impedance testing to measure acid reflux objectively. Complications will be graded using the Clavien-Dindo classification for surgical events and the AGREE classification for endoscopic events. Because one treatment is endoscopic and the other is laparoscopic, neither the participants nor the operators can be masked. To protect against biased outcome assessment, the investigators reporting manometry, endoscopy, barium studies and pH-impedance, the trial statistician and the endpoint adjudication committee will all be masked to treatment allocation. The trial will be conducted at Minia University Hospital, Faculty of Medicine, Minia University, Minia, Egypt, with provision for expansion to additional tertiary centers under a common standard-operating-procedure manual.

Official title: Peroral Endoscopic Myotomy (POEM) Versus Laparoscopic Heller Cardiomyotomy With Dor Fundoplication for the Treatment of Oesophageal Achalasia: A Randomized Controlled Trial

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