POEM Versus Laparoscopic Heller Myotomy With Dor Fundoplication for Esophageal Achalasia

Description

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.

Interventions

• Peroral endoscopic myotomy (Procedure)
  Under general anesthesia with endotracheal intubation and CO2 insufflation, after 48 hours of clear-liquid diet, an overnight fast and on-table esophageal lavage, a longitudinal mucosal incision is made approximately 10 to 12 cm proximal to the esophagogastric junction following submucosal lift. A submucosal tunnel is dissected distally across the junction and 2 to 3 cm onto the gastric cardia, confirmed by palisade vessels, junctional narrowing and a retroflexion check. A selective circular-muscle or full-thickness myotomy, recorded as performed, extends from approximately 7 to 10 cm above the junction to 2 to 3 cm below it, giving a total myotomy length of approximately 8 to 12 cm, and may be lengthened for type III spastic disease. The mucosal entry is closed with endoscopic clips or an equivalent closure device. Endoscopists must have performed at least 20 prior POEM procedures.
• Laparoscopic Heller myotomy with Dor fundoplication (Procedure)
  Under general anesthesia with endotracheal intubation, a standard laparoscopic approach with 4 to 5 ports is used, the left lobe of the liver retracted and the esophagogastric junction exposed with limited hiatal dissection preserving the posterior attachments. An anterior longitudinal myotomy of the circular and longitudinal muscle layers extends approximately 6 cm onto the distal esophagus and 2 to 3 cm onto the gastric cardia. Mucosal integrity is confirmed by intraoperative endoscopy and/or an air-leak submersion test. A Dor anterior partial fundoplication of 180 to 200 degrees is constructed over the exposed mucosa. Conversion to open surgery for safety is recorded as a protocol deviation, and the participant remains in the assigned arm for the intention-to-treat analysis. Surgeons must have performed at least 20 prior laparoscopic Heller myotomy procedures.

Eligibility criteria

Conditions

Locations

• Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University — Minya, Minya Governorate, Egypt