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

8 mei 2026 bijgewerkt door: Mohan Ramchandani, Asian Institute of Gastroenterology, India

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Primary Objective

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. Secondary Objectives

  1. To compare composite forceps use (rescue + prophylactic) between groups.
  2. To evaluate the frequency of prophylactic-only forceps use.
  3. To compare total number of forceps applications per procedure.
  4. To determine differences in intra-procedural bleeding episodes.
  5. To compare procedural efficiency (procedure time, number of instrument exchanges).
  6. To compare hematological and inflammatory markers (Hb drop, Hct, CRP, WBC).
  7. To compare delayed bleeding rates within 30 days.
  8. To evaluate overall complication rates (intra- and post-procedural).
  9. To assess patient-reported outcomes (pain, tolerability). A prospective, randomized, open-label, parallel-group, controlled clinical trial.

Study Arms 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.

Control Arm: Conventional Coagulation (CO₂ Setting)

  • Standard vessel isolation and coagulation under CO₂ insufflation.
  • SWIFT COAG: E3 (89 W) for POEM.

Studietype

Observationeel

Inschrijving (Geschat)

120

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Indië
    • Telangana
      • Hyderabad, Telangana, Indië, 500082
        • Werving
        • Asian Institute of Gastroenterology Hospital
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

120 (60 in each arm)

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: Under Water Preventive Coagulation

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.
Conventional Coagulation

Control Arm: Conventional Coagulation (CO₂ Setting)

  • Standard vessel isolation and coagulation under CO₂ insufflation.
  • SWIFT COAG: E3 (89 W) for POEM.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
Tijdsspanne: 60 minutes
  1. Underwater preventive vessel coagulation, and
  2. Conventional vessel coagulation under CO₂ insufflation.
60 minutes

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To compare composite forceps use (rescue + prophylactic) between groups.
Tijdsspanne: 60 minutes

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

1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
60 minutes
To evaluate the frequency of prophylactic-only forceps use.
Tijdsspanne: 60 minutes

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

1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
60 minutes
To compare total number of forceps applications per procedure.
Tijdsspanne: 60 minutes

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

1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
60 minutes
To determine differences in intra-procedural bleeding episodes
Tijdsspanne: 60 minutes

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

1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
60 minutes
To compare procedural efficiency (procedure time, number of instrument exchanges
Tijdsspanne: 60 minutes

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

1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
60 minutes
To compare hematological and inflammatory markers (Hb drop, Hct, CRP, WBC)
Tijdsspanne: 24 hours

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

1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
24 hours
To compare delayed bleeding rates
Tijdsspanne: 30 days
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
30 days
To evaluate overall complication rates (intra- and post-procedural)
Tijdsspanne: 24 hours

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

1.Underwater preventive vessel coagulation, and Conventional vessel coagulation under CO₂ insufflation
24 hours
To assess patient-reported outcomes (pain, tolerability).
Tijdsspanne: 72 hours

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Asian Institute of Gastroenterology, India

Onderzoekers

  • Studie directeur: Mohan Dr Ramchandani, MD DM, Asian Institute of Gastroenterology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2026

Primaire voltooiing (Geschat)

10 mei 2027

Studie voltooiing (Geschat)

30 december 2027

Studieregistratiedata

Eerst ingediend

4 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

8 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • POEM UWC 2026

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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