A Randomized Controlled Trial Comparing Underwater Versus Conventional Preventive Coagulat
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 cu
| Condition(s) | Vessel Puncture Site Reaction |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 coagulation under CO₂ insufflation using the hybrid knife (HK). However, this approach can require additional hemostatic devices-most commonly coagulation forceps-particularly when dealing with large-calibre vessels or resistant bleeding. A novel technique-underwater preventive coagulation-leverages water as a conductive medium. Preliminary evidence suggests that: * electrosurgical current in water |
| Who can participate | 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/gastric varices 4. Previous POEM or Heller's myotomy 5. Prior treatment for same condition 6. Inability or refusal to consent 7. Visualized vessels smaller than the HK inner diameter (1.2 mm) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Asian Institute of Gastroenterology, India |
| Locations | Hyderabad, Telangana, India |
| Start date | 2026-02-01 |
| NCT ID | NCT07575295 |
| Official listing | https://clinicaltrials.gov/study/NCT07575295 |