NCT06042127 POEM-F for Achalasia International Study
| NCT ID | NCT06042127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Achalasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 81 participants in total. It began in 2023-12-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy. The main concern with POEM is the higher incidence of post-procedure gastroesophageal reflux disease (GERD), occurring in up to 50-60% of patients. In order to reduce the risk of GERD, endoscopic fundoplication has been developed as a novel procedure mimicking surgical anterior partial fundoplication that can be performed in the same session as POEM (POEM-F). Case series of POEM-F in patients with achalasia reported encouraging outcomes of low GERD rate of \~12% at 1 year. Prospective comparative data between POEM-F and conventional POEM on post-procedure GERD is current lacking. The investigators therefore designed an international multicenter prospective randomized study to investigate the efficacy of POEM-F. The investigators postulate that POEM-F could reduce the incidence of post-procedure GERD when compared with conventional POEM. This is an international multicenter randomized controlled trial conducted between high volume expert centers from Hong Kong SAR, China, India and United States of America. Adult patients with manometry confirmed achalasia would be randomised to undergo POEM-F or POEM. The procedure would be performed by experts with vast experience in POEM. The primary outcome is the incidence of post-procedure GERD at 1 year, defined by the updated Lyon consensus. Secondary outcomes include technical and clinical success rates, adverse events, post-POEM endoscopic and manometry findings as well as patients' symptom scores. Sample size calculation Based on existing pilot comparative data on POEM-F and POEM, it is estimated that 84 patients would be required to demonstrate a difference in post-procedure GERD of 47.6% to 18.2%, with 80% power and false positive rate of 0.05, accounting for 10% loss to follow-up. Purpose and potential The current study proposal could demonstrate the superiority of POEM-F over POEM in reducing post-procedural GERD. It would also demonstrate the safety and reproducibility of the technique in expert centers across the globe. It could potentially replace conventional POEM as the preferred minimally invasive endoscopic treatment for achalasia.
Eligibility Criteria
Inclusion criteria: 1. Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II. 2. Capability of understanding and complying with the study requirements, including filling the Eckardt Score, GERD-HRQL and RSI questionnaire and signing the informed consent form. 3. Patients with achalasia type I, II or III who are one of the following: * Treatment naïve, or * Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation Exclusion criteria: 1. Patients unable or unwilling to provide consent. 2. Previous esophageal or gastric surgery. 3. Prior achalasia treatment including Heller myotomy, POEM. 4. Sigmoid achalasia, or significant esophageal dilatation \>6cm in lower esophagus 5. Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc 6. Patients with large hiatal hernias (axial length \> 2 cm and Hill grade \>2). 7. Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above. 8. Patients with obesity (Body Mass Index (BMI) ≥ 30). 9. Pregnant women or those planning pregnancy or breastfeeding women. 10. Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.
Contact & Investigator
Hon Chi Yip, FRCSEd
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06042127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Achalasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06042127 currently recruiting?
Yes, NCT06042127 is actively recruiting participants. Contact the research team at hcyip@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT06042127 trial being conducted?
This trial is being conducted at Baltimore, United States, Guangzhou, China, Hong Kong, Hong Kong, Chandigarh, India and 3 additional locations.
Who is sponsoring the NCT06042127 clinical trial?
NCT06042127 is sponsored by Chinese University of Hong Kong. The principal investigator is Hon Chi Yip, FRCSEd at Chinese University of Hong Kong. The trial plans to enroll 81 participants.