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

2026年5月8日 更新者：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

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 印度
    • Telangana
      • Hyderabad、Telangana、印度、500082
        • 招聘中
        • Asian Institute of Gastroenterology Hospital
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

120 (60 in each arm)

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
To compare the proportion of POEM patients requiring rescue haemostasis with coagulation forceps (for active bleeding) between:
大体时间：60 minutes
  1. Underwater preventive vessel coagulation, and
  2. Conventional vessel coagulation under CO₂ insufflation.
60 minutes

次要结果测量

结果测量
措施说明
大体时间
To compare composite forceps use (rescue + prophylactic) between groups.
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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).
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Asian Institute of Gastroenterology, India

调查人员

  • 研究主任：Mohan Dr Ramchandani, MD DM、Asian Institute of Gastroenterology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月1日

初级完成 (估计的)

2027年5月10日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • POEM UWC 2026

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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