A Randomized Controlled Trial Comparing Underwater Versus Conventional Preventive Coagulation for Intraprocedural Vessel Management During Peroral Endoscopic Myotomy
Recruiting
Observational Study
Vessel Puncture Site Reaction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Observational
- Participants needed
- 120 (estimated)
- Sponsor
- Asian Institute of Gastroenterology, India · Other
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About This Trial
Peroral Endoscopic Myotomy (POEM) has become an established, minimally invasive therapy for achalasia and esophageal motility disorders. Submucosal tunnelling is a critical phase of POEM and requires meticulous haemostasis to avoid bleeding, loss of orientation, reduced visibility, and prolonged procedural time.
The current standard method of vessel coagulation during POEM involves conventional c…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. Diagnosis of achalasia or esophageal motility disorder planned for POEM
3. Ability to provide informed consent
Exclusion Criteria:
1. Anticoagulant or antithrombotic therapy not safely stoppable
2. Known coagulopathy or platelet disorder
3. Esophageal/gast…
Contacts