POEM Versus Laparoscopic Heller Myotomy With Dor Fundoplication for Esophageal Achalasia

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.

Inclusion Criteria: * Age 18 to 75 years. * New diagnosis of primary achalasia confirmed by high-resolution manometry according to the Chicago Classification version 4.0 (elevated median integrated relaxation pressure with 100% failed peristalsis), of any subtype (I, II or III). * Eckardt symptom score of 4 or more at baseline. * Upper endoscopy excluding mechanical obstruction, malignancy and pseudoachalasia. * Treatment-naive with respect to definitive therapy (no prior Heller myotomy, prior POEM or prior pneumatic dilation). Prior botulinum-toxin injection is permitted if administered at least 6 months before enrollment. * Fit for general anesthesia (American Society of Anesthesiologists physical status I to III). * Able to provide written informed consent and to comply with the follow-up schedule. Exclusion Criteria: * Prior esophageal or gastric surgery, prior myotomy (surgical or endoscopic), or prior pneumatic dilation. * Secondary (pseudo-) achalasia, suspected or confirmed esophagogastric malignancy, or eosinophilic esophagitis. * Sigmoid or end-stage megaesophagus (tortuous, dilated greater than 7 cm) considered unsuitable for myotomy. * Severe esophageal varices, significant coagulopathy, or therapy with anticoagulants that cannot be safely interrupted. * Significant cardiopulmonary disease precluding general anesthesia or capnoperitoneum / capnomediastinum. * Pregnancy or breastfeeding. * Body mass index below 18.5 kg/m2 with severe malnutrition requiring prior nutritional optimization (may be re-screened after optimization). * Inability to provide informed consent or anticipated non-compliance with follow-up.