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

NCT07575295 | Recruiting DMC

• 1 other identifier: POEM UWC 2026
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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)
• Identify the esophagogastric junction (EGJ).
• Inject saline + methylene blue submucosally.
• Create a 2 cm mucosal incision at 5-6 o'clock position, 10 cm above EGJ.
• Enter the submucosal space.
• Perform submucosal tunnelling down to EGJ and 2-3 cm into cardia.
• Perform vessel haemostasis according to group allocation:
• Underwater coagulation (intervention)
• CO₂-based conventional coagulation (control)
• Perform circular myotomy (with occasional full-thickness myotomy when indicated).
• Close the mucosal entry using hemostatic clips.
• Record procedure time, instrument exchanges, bleeding events, and forceps usage.
• 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

Vessel Puncture Site Reaction

Outcome Measures

Primary Outcomes (1)

• To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:

  1. Underwater preventive vessel coagulation, and 2. Conventional vessel coagulation under CO₂ insufflation.

  60 minutes

Secondary Outcomes (9)

• To compare composite forceps use (rescue + prophylactic) between groups.

  60 minutes

• To evaluate the frequency of prophylactic-only forceps use.

  60 minutes

• To compare total number of forceps applications per procedure.

  60 minutes

• To determine differences in intra-procedural bleeding episodes

  60 minutes

• To compare procedural efficiency (procedure time, number of instrument exchanges

  60 minutes

Study Arms (2)

Under Water Coagulation

Intervention Arm: Underwater Coagulation * Vessel coagulation performed entirely underwater using the Hybrid Knife. * SWIFT COAG: E3 (89 W) for POEM. * Physiological saline instilled to completely displace air around the target vessel.

Other: Under Water Preventive Coagulation

Conventional Coagulation

Control Arm: Conventional Coagulation (CO₂ Setting) * Standard vessel isolation and coagulation under CO₂ insufflation. * SWIFT COAG: E3 (89 W) for POEM.

Interventions

Under Water Preventive Coagulation OTHER

Leverages water as a conductive medium. Preliminary evidence suggests that: 1. electrosurgical current in water is focalized at the interface of the vessel, 2. allowing a soft sealing of the vessel wall, 3. reducing the risk of vessel rupture or unintended deep thermal injury, 4. and potentially eliminating the need to convert to coagulation forceps.

Under Water Coagulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

120 (60 in each arm)

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)

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology Hospital

Hyderabad, Telangana, 500082, India

RECRUITING

Study Officials

• Mohan Dr Ramchandani, MD DM

  Asian Institute of Gastroenterology

  STUDY DIRECTOR

Central Study Contacts

Rajesh Goud Mr Maragoni, M.Pharm

CONTACT

04023378888; rajeshgoud761@gmail.com

Zaheer Nabi Dr Mohammed, MD DNB

CONTACT

04023378888; zaheernabi1978@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

IN (1)