New procedure for treating achalasia to reduce reflux
Per-oral Endoscopic Myotomy With Fundoplication for Achalasia - an International Multicenter Randomized Controlled Trial
This study is testing a new procedure for treating achalasia to see if it can reduce the chance of reflux in adults who have trouble swallowing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 7 sites (Baltimore, Maryland and 6 other locations) |
| Trial ID | NCT06042127 on ClinicalTrials.gov |
What this trial studies
This international multicenter study investigates the efficacy of a novel procedure called per-oral endoscopic myotomy with fundoplication (POEM-F) for treating achalasia, a condition characterized by difficulty swallowing. The study aims to compare the incidence of gastroesophageal reflux disease (GERD) between patients undergoing POEM-F and those receiving conventional POEM. By performing both procedures in the same session, the researchers hope to minimize the risk of GERD, which is a common complication of POEM. The study will include adult patients aged 18 to 65 with symptomatic achalasia types I or II, and will assess outcomes through various questionnaires and clinical evaluations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with symptomatic achalasia types I or II, who are either treatment naïve or have failed prior balloon dilation treatments.
Not a fit: Patients with previous esophageal or gastric surgery, or those with significant comorbidities that may limit their ability to participate, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of GERD in patients undergoing treatment for achalasia.
How similar studies have performed: While POEM has been established as an effective treatment for achalasia, the specific combination of POEM-F is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland and 6 other locations
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Not_yet_recruiting)
- Nanfang Hospital, Southern Medical University — Guangzhou, China (Not_yet_recruiting)
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
- Post Graduate Institute of Medical Education and Research — Chandigarh, India (Not_yet_recruiting)
- Asian Institute of Gastroenterology — Hyderabad, India (Not_yet_recruiting)
- Baldota Institute of Digestive Sciences — Mumbai, India (Not_yet_recruiting)
- Deenanath Mangeshkar Hospital & Research Center — Pune, India (Not_yet_recruiting)
Study contacts
- Principal investigator: Hon Chi Yip, FRCSEd — Chinese University of Hong Kong
- Study coordinator: Hon Chi Yip, FRCSEd
- Email: hcyip@surgery.cuhk.edu.hk
- Phone: 35052627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.