💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Peroral endoscopic myotomy
- Laparoscopic Heller myotomy with Dor fundoplication
Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University
Minya, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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