POEM-F for Achalasia International Study

Recruiting now · Not applicable

Conditions studied: Achalasia

In brief

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.

Key facts

Study ID: NCT06042127
Run by: Chinese University of Hong Kong
People needed: 81
Starts: 2023-12-01
Expected to finish: 2026-10-31
Last updated by the study team: 2024-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II.
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.
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

You may not qualify if…

Patients unable or unwilling to provide consent.
Previous esophageal or gastric surgery.
Prior achalasia treatment including Heller myotomy, POEM.
Sigmoid achalasia, or significant esophageal dilatation >6cm in lower esophagus
Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc
Patients with large hiatal hernias (axial length > 2 cm and Hill grade >2).
Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.
Patients with obesity (Body Mass Index (BMI) ≥ 30).
Pregnant women or those planning pregnancy or breastfeeding women.
Uncorrectable coagulopathy defined by international normalized ratio (INR) > 1.5 or platelet count < 50000/µl.

Where it is running

The Chinese University of Hong Kong — Hong Kong, Hong Kong (enrolling)
Nanfang Hospital, Southern Medical University — Guangzhou, China
Johns Hopkins Hospital — Baltimore, Maryland, United States
Asian Institute of Gastroenterology — Hyderabad, India
Baldota Institute of Digestive Sciences — Mumbai, India
Deenanath Mangeshkar Hospital & Research Center — Pune, India
Post Graduate Institute of Medical Education and Research — Chandigarh, India

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.