NCT06042127 · Chinese University of Hong Kong
POEM-F for Achalasia International Study
What this study is about
Per-taken by mouth 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.
View original scientific description
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.
Interventions
PROCEDURE
POEM-F
POEM-F would be performed as described in the arms section
PROCEDURE
Conventional POEM
Anterior POEM performed as described in the arms section
Primary outcome measures
Post-procedure rate of gastroesophageal reflux
Time frame: 1 year
Defined by updated Lyon 2.0 consensus as fulfilling one or more of the criteria: 1. Endoscopic erosive esophagitis, LA grade B or above 2. Long segment Barrett's esophagus 3. Peptic esophageal stricture 4. 24-hour pH study with acid exposure time \>6% Both endoscopy and pH study to be performed with proton pump inhibitor stopped for 4 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Baltimore, Maryland
Collaborators
Deenanath Mangeshkar Hospital and Research Centre, Johns Hopkins University, Northwestern University, Nanfang Hospital, Southern Medical University, Asian Institute of Gastroenterology, India, Post Graduate Institute of Medical Education and Research, Chandigarh
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Dec 3, 2024 · Source of record for eligibility and locations