Actively Recruiting
A Randomized Controlled Trial Comparing Underwater Versus Conventional Preventive Coagulation for Intraprocedural Vessel Management During Peroral Endoscopic Myotomy
Led by Asian Institute of Gastroenterology, India · Updated on 2026-05-12
120
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 is focalized at the interface of the vessel, * allowing a soft sealing of the vessel wall, * reducing the risk of vessel rupture or unintended deep thermal injury, * and potentially eliminating the need to convert to coagulation forceps. Pilot data from our center demonstrate that underwater prophylactic sealing of large vessels during POEM is feasible, safe, and associated with markedly reduced need for rescue coagulation forceps. The technique is already used in practice but lacks systematic evidence from prospective randomized trials. This study is designed to provide high-quality evidence on whether underwater vessel coagulation improves haemostatic efficiency, reduces intra-procedural bleeding, and minimizes device changes during POEM. All POEM procedures will be performed under general anesthesia in the supine position using Fujifilm high-definition gastroscopes with a 2.8 mm channel and transparent distal cap. Steps (Both Arms) 1. Identify the esophagogastric junction (EGJ). 2. Inject saline + methylene blue submucosally. 3. Create a 2 cm mucosal incision at 5-6 o'clock position, 10 cm above EGJ. 4. Enter the submucosal space. 5. Perform submucosal tunnelling down to EGJ and 2-3 cm into cardia. 6. Perform vessel haemostasis according to group allocation: * Underwater coagulation (intervention) * CO₂-based conventional coagulation (control) 7. Perform circular myotomy (with occasional full-thickness myotomy when indicated). 8. Close the mucosal entry using hemostatic clips. 9. Record procedure time, instrument exchanges, bleeding events, and forceps usage. Equipment * Hybrid Knife (Erbe Elektromedizin GmbH) * VIO 3 generator + ERBEJet 2 water-jet system * Methylene-blue tinted saline * Electrosurgical settings: ENDO CUT Q 2-3-3 for mucosal incision and myotomy
CONDITIONS
Official Title
A Randomized Controlled Trial Comparing Underwater Versus Conventional Preventive Coagulation for Intraprocedural Vessel Management During Peroral Endoscopic Myotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of achalasia or esophageal motility disorder planned for POEM
- Ability to provide informed consent
You will not qualify if you...
- Anticoagulant or antithrombotic therapy that cannot be safely stopped
- Known coagulopathy or platelet disorder
- Presence of esophageal or gastric varices
- Previous POEM or Heller's myotomy procedure
- Prior treatment for the same condition
- Inability or refusal to provide consent
- Visualized vessels smaller than 1.2 mm in diameter (Hybrid Knife inner diameter)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asian Institute of Gastroenterology Hospital
Hyderabad, Telangana, India, 500082
Actively Recruiting
Research Team
R
Rajesh Goud Mr Maragoni, M.Pharm
CONTACT
Z
Zaheer Nabi Dr Mohammed, MD DNB
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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