Comparing different myotomy techniques for treating achalasia
Comparison Study of Conventional Peroral Endoscopic Myotomy (POEM) and Different Modified Procedures of POEM for Achalasia
NA · Peking Union Medical College Hospital · NCT04578769
This study is testing different surgical techniques for treating achalasia to see if newer, shorter methods can help patients feel better just as well as the traditional ones.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04578769 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of various modified peroral endoscopic myotomy (POEM) techniques for patients with type I, II, and III achalasia. It will compare conventional myotomy methods, such as long and circular myotomy, with modified approaches like short and tailored myotomy. The study will involve patients diagnosed with achalasia based on established diagnostic methods and will assess outcomes such as procedure time and postoperative symptom relief. The goal is to determine if shorter or tailored myotomy techniques can provide similar benefits to traditional methods while potentially reducing procedure duration.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14 to 70 diagnosed with type I, II, or III achalasia.
Not a fit: Patients who have previously undergone myotomy for achalasia or have certain anatomical esophageal anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and efficient treatment options for patients with achalasia.
How similar studies have performed: Previous retrospective studies have suggested that shorter myotomy techniques may be comparable to longer ones, but this study aims to provide more definitive prospective evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed as achalasia type I or II according to the Chicago Classification Version 4.0, with an Eckardt score \>3 * Their age is ≥14years and ≤70 years * Able to give written consent Exclusion Criteria: * undergone previous surgical treatments * had contra-indication to general anesthesia * previous surgery of the mediastinum, stomach, or esophagus; * Pregnant or lactating female * type III achalasia * current alcohol or drug addiction, mental retardation, severe congenital or acquired coagulopathy (international normalized ratio \>1.6) * hepatic cirrhosis with or without portal hypertension, eosinophilic esophagitis (biopsies were performed at index endoscopy), or confirmed Barrett's esophagus * esophageal diverticula or hiatal hernia based on findings from the index barium esophagram, or other conditions that the investigator believed not appropriate for POEM procedure
Where this trial is running
Beijing, Beijing Municipality
- Department of Gastroenterology, Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Tao Guo, MD — Peking Union Medical College Hospital
- Study coordinator: Tao Guo, MD
- Email: guoqiong990@126.com
- Phone: 8610-69155017
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.
Conditions: Esophageal Achalasia, peroral endoscopic myotomy, Achalasia, thickness of myotomy