Pilot study of a new procedure for achalasia treatment
Per-oral Endoscopic Myotomy With Fundoplication (POEM+F) for Achalasia - a Pilot Study
This study is testing a new procedure that combines two treatments for achalasia to see if it can help patients feel better and reduce acid reflux after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05214443 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of combining per-oral endoscopic myotomy (POEM) with endoscopic fundoplication in patients with achalasia. The study will recruit 10 patients to investigate the novel POEM procedure using a new X-tack anchoring device, which may help reduce the incidence of post-procedural acid reflux, a common complication of POEM. By integrating fundoplication during the POEM procedure, the researchers hope to enhance patient outcomes and minimize adverse effects associated with traditional POEM. The study is being conducted at the Chinese University of Hong Kong.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with achalasia through high-resolution manometry and scheduled for elective POEM.
Not a fit: Patients who have previously undergone treatment for achalasia or have had upper abdominal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-procedural reflux in achalasia patients undergoing POEM.
How similar studies have performed: Previous studies have shown promise in combining POEM with fundoplication, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion criteria 1. Patients with achalasia diagnosed with high resolution manometry, scheduled for elective per-oral endoscopic myotomy 2. Age \>18 * Exclusion criteria 1. Prior treatment for achalasia, including surgical myotomy, dilatation or POEM. 2. Prior upper abdominal surgery 3. Other cases deemed by the examining physician as unsuitable for safe treatment 4. Patients who refused to participate
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (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.