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

8 maj 2026 uppdaterad av: 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

120

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Indien
    • Telangana
      • Hyderabad, Telangana, Indien, 500082
        • Rekrytering
        • Asian Institute of Gastroenterology Hospital
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

120 (60 in each arm)

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To compare composite forceps use (rescue + prophylactic) between groups.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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).
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Asian Institute of Gastroenterology, India

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2026

Primärt slutförande (Beräknad)

10 maj 2027

Avslutad studie (Beräknad)

30 december 2027

Studieregistreringsdatum

Först inskickad

4 maj 2026

Först inskickad som uppfyllde QC-kriterierna

4 maj 2026

Första postat (Faktisk)

8 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • POEM UWC 2026

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Nej

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