POEM Versus Laparoscopic Heller Myotomy With Dor Fundoplication for Esophageal Achalasia

NCT07814027 | Recruiting DMC

• 1 other identifier: 2120:9/26
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Achalasia; Esophageal Motility Disorders; Gastroesophageal Reflux

Keywords

Peroral endoscopic myotomy; POEM; Heller myotomy; Dor fundoplication; Achalasia; Eckardt score; High-resolution manometry; Chicago Classification v4.0; Gastroesophageal reflux disease; Minimally invasive esophageal surgery

Outcome Measures

Primary Outcomes (1)

• Clinical success at 12 months

  Proportion of participants with clinical success, defined as a total Eckardt symptom score of 3 or less and no retreatment for achalasia between the index procedure and the 12-month assessment. Retreatment includes pneumatic dilation, repeat or rescue myotomy by either modality, or surgical revision. The Eckardt symptom score is the sum of four component scores-dysphagia, regurgitation, retrosternal pain, and weight loss-with each component scored from 0 to 3; total scores range from 0 to 12, with higher scores indicating more severe symptoms. Participants who undergo retreatment or have an Eckardt symptom score greater than 3 at 12 months will be classified as treatment failures.

  12 months after the index procedure

Secondary Outcomes (13)

• Gastroesophageal reflux symptoms measured by the GERD-HRQL total score

  3, 6, and 12 months after the index procedure

• Erosive reflux esophagitis of Los Angeles grade B or worse

  3 and 12 months after the index procedure

• Pathological esophageal acid exposure on 24-hour pH-impedance monitoring

  3 months after the index procedure; repeated at 12 months for participants in the prespecified objective-reflux substudy or when clinically indicated

• Eckardt symptom score and component scores

  3, 6, and 12 months after the index procedure

• Esophagogastric junction relaxation measured by integrated relaxation pressure

  3 and 12 months after the index procedure

Study Arms (2)

Peroral endoscopic myotomy (POEM)

EXPERIMENTAL

Participants undergo peroral endoscopic myotomy under general anesthesia. No anti-reflux procedure is performed. Routine proton-pump inhibitor therapy at standard once-daily dose is offered for the first 8 weeks and continued thereafter on the basis of symptoms and objective reflux testing.

Procedure: Peroral endoscopic myotomy

Laparoscopic Heller myotomy with Dor fundoplication

ACTIVE COMPARATOR

Participants undergo laparoscopic Heller myotomy with a Dor anterior partial fundoplication under general anesthesia. Routine proton-pump inhibitor therapy at standard once-daily dose is offered for the first 8 weeks and continued thereafter under identical decision rules to those applied in the experimental arm.

Procedure: Laparoscopic Heller myotomy with Dor fundoplication

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.

Also known as: POEM Endoscopic /myotomy Submucosal tunneling /endoscopic myotomy

Peroral endoscopic myotomy (POEM)

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.

Also known as: LHM plus Dor /Laparoscopic Heller cardiomyotomy/ Heller-Dor procedure

Laparoscopic Heller myotomy with Dor fundoplication

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Related Publications (1)

• Khashab MA, Vela MF, Thosani N, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Jamil LH, Jue TL, Kannadath BS, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Yang J, Wani S. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020 Feb;91(2):213-227.e6. doi: 10.1016/j.gie.2019.04.231. Epub 2019 Dec 13.

  PMID: 31839408 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia; Esophageal Motility Disorders; Gastroesophageal Reflux

Interventions

Heller Myotomy; Receptors, Opioid, delta

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy; Receptors, Opioid; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Neuropeptide; Receptors, Neurotransmitter; Receptors, Peptide

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh Khairy K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)/ Masking of participants and operators is not feasible because one intervention is endoscopic and the other laparoscopic. Outcome assessors performing and reporting high-resolution manometry, upper endoscopy with esophagitis grading, timed barium esophagram and 24-hour pH-impedance, together with the trial statistician and the endpoint adjudication committee, are masked to allocation. Participant-reported instruments are collected by masked coordinators using standardized scripts. Any unmasking is documented with justification.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of General Surgery, Department of Surgery, Faculty of Medicine

Model Details: Two-arm, parallel-group, 1:1 randomized non-inferiority trial with a pre-specified margin of 12.5 percentage points, stratified by achalasia subtype (Chicago Classification type I or II versus type III) and, if more than one centre participates, by centre.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 10, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): September 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)