A Randomized Controlled Trial Comparing Underwater Versus Conventional Preventive Coagulation for Intraprocedural Vessel Management During Peroral Endoscopic Myotomy

Recruiting now

Conditions studied: Vessel Puncture Site Reaction

In brief

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

Key facts

Study ID

NCT07575295

Run by

Asian Institute of Gastroenterology, India

People needed

120

Starts

2026-02-01

Expected to finish

2027-12-30

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Diagnosis of achalasia or esophageal motility disorder planned for POEM
• Ability to provide informed consent

You may not qualify if…

• Anticoagulant or antithrombotic therapy not safely stoppable
• Known coagulopathy or platelet disorder
• Esophageal/gastric varices
• Previous POEM or Heller's myotomy
• Prior treatment for same condition
• Inability or refusal to consent
• Visualized vessels smaller than the HK inner diameter (1.2 mm)

Where it is running

• Asian Institute of Gastroenterology Hospital — Hyderabad, Telangana, India (enrolling)

Full record on ClinicalTrials.gov

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