POEM vs Heller myotomy with Dor fundoplication for achalasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with newly diagnosed primary achalasia are randomized to receive either peroral endoscopic myotomy (POEM) or laparoscopic Heller myotomy with Dor fundoplication. The study compares symptom relief and outcomes related to esophageal function, reflux, and safety over follow-up. Procedures aim to reduce the obstruction at the esophagogastric junction, but POEM may have a higher risk of reflux while Heller with Dor includes a built-in anti-reflux component. The trial builds on previous evidence suggesting similar short- to medium-term success, while addressing durability and reflux in broader clinical settings.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Saleh K Saleh, MD — Minia University
• Study coordinator: Saleh Khairy K Saleh, MD
• Email: salehkhairy@mu.edu.eg
• Phone: 01201765401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.