Underwater versus standard vessel sealing during POEM

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

This trial tests whether sealing blood vessels underwater during POEM reduces the need for rescue coagulation in adults having POEM for achalasia or other esophageal motility disorders.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Asian Institute of Gastroenterology, India (Academic / other)
• Locations: 1 site (Hyderabad, Telangana)
• Trial ID: NCT07575295 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, open-label, parallel-group trial comparing underwater preventive vessel coagulation to conventional coagulation under CO2 insufflation during the submucosal tunnelling phase of POEM. Participants are randomized to vessel coagulation performed entirely underwater with saline using the Hybrid Knife (SWIFT COAG E3, 89 W) or to standard coagulation under CO2 insufflation with the same energy setting. The primary outcome is the proportion of patients requiring rescue haemostasis with coagulation forceps for active bleeding; multiple secondary outcomes include composite forceps use, intra-procedural bleeding episodes, procedure time, instrument exchanges, hematologic/inflammatory markers, delayed bleeding, complications, and patient-reported tolerability. The trial is conducted at the Asian Institute of Gastroenterology Hospital in Hyderabad, India.

Who should consider this trial

Good fit: Adults (≥18 years) with achalasia or other esophageal motility disorders scheduled for a first-time POEM who can safely stop anticoagulant/antithrombotic therapy and provide informed consent are ideal candidates.

Not a fit: Patients who cannot safely stop anticoagulants, have known coagulopathy or varices, have had prior POEM or Heller myotomy, or whose visible vessels are smaller than the device inner diameter are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the technique could lower the need for rescue coagulation, reduce bleeding-related complications, and shorten or simplify the POEM procedure.

How similar studies have performed: Preliminary bench and early clinical reports suggest underwater electrosurgery can focalize thermal effect and reduce vessel rupture, but randomized data for this underwater preventive coagulation approach in POEM are limited and the technique remains relatively novel.

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/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)

Where this trial is running

Hyderabad, Telangana

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

Study contacts

• Study coordinator: Rajesh Goud Mr Maragoni, M.Pharm

Conditions Vessel Puncture Site Reaction