A Randomized Comparison of UnderwateR Versus Regular Coagulation in Endoscopic Submucosal DissectioN and Third Space Endoscopy

March 31, 2025 updated by: Istituto Clinico Humanitas

What the investigatorpropose in this protocol is a technique already used in clinical practice. It prevents the risk of bleeding and make third space endoscopy easier, quicker, safer and cheaper. Indeed, we noticed that preventive underwater coagulation of the candidate vessels during the submucosal dissection with the Hybrid Knife (HK), seal the wall of the vessel, resulting in a subsequent cut under CO2 without any bleeding. Such preventive coagulation is likely to be related with the conduction of the current underwater as it focalizes all the power on the interface between the vessel and the water, allowing a soft sealing of the vessel without cutting it. Despite widely used, there is no evidence up to know on the benefit and harm of such coagulation technique.

The hypothesis is that the use of this approach in clinical practice, especially when used to coagulate a vessel, may lead to an increase in safety, feasibility and cost-effectiveness, reducing the procedural time, the rate of complications and the need for coagulation forceps in comparison with the conventional preventive coagulation technique under CO2 insufflation. Therefore, this randomized study compares the underwater coagulation technique with the conventional coagulation technique in the CO2 setting during the submucosal dissection in third space endoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

POEM will be performed under general anaesthesia in the supine position. The location of the esophagogastric junction (EGJ) will be identified and, then, after submucosal injection of saline mixed with methylene blue, a 2-cm mucosal incision carried out at 5-6 o'clock position about 10 cm above the EGJ. After, a dissection of the underlying submucosa will be performed to access the submucosal space. Then, the dissection of the submucosal layer will be continued to create the submucosal tunnel down to the narrower submucosal space at the EGJ and 2-3 cm into the cardia. During the submucosal tunnelling, coagulation of vessels will be performed with HK using SWIFT COAG E3, 89 W in the underwater setting in the treatment arm or with the standard technique in the CO2-setting in the conventional group. After, the myotomy of the circular muscular layer will be performed from 2-3 cm below the mucosal incision until 2-3 cm below the EGJ in both groups. In some cases, a full thickness myotomy, including the longitudinal muscular layer, will be carried out. Finally, complete closure of the mucosal entry site will be achieved with haemostatic clips. The procedure time, the number of instrument exchanges and bleeding episodes requiring the use of coagulation forceps during the procedure will be documented from start of submucosal tunnelling until final clip closure in both groups.

Fujifilm high-definition gastroscopes (Fujifilm Co., Tokyo, Japan) with a 2.8-mm operative channel and a transparent distal cap attachment will be used in both groups. A submucosal lift with saline mixed with methylene blue through a 23 G injection needle will be accomplished for the mucosal entry. POEM will be carried out using a HK (Erbe Elektromedizin GmbH, Tübingen) in both groups. This instrument has an outer diameter of 2.1 mm and an inner diameter of 1.2 mm with both electrosurgical and water-jet (WJ) surgery technologies in one device. The HK combines needle-less submucosal injection, cutting, dissection and coagulation in one instrument. The modular VIO generator (VIO 3, Erbe Elektromedizin GmbH, Tübingen, Germany) will be used as an electrosurgical system in combination with the ERBEJet 2 WJ surgery system in both groups. A slightly methylene blue-stained isotonic saline solution will be used for submucosal injection with the WJ technique in both groups. Mucosal incision and myotomy will be carried out using ENDO CUT Q 2-3-3 and ENDO CUT Q 2-3-3, respectively, in both groups.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20089
        • Humanitas Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

All >18 years-old patients undergoing ESD for superificial GI neoplastic lesions or POEM for esophageal achalasia

Exclusion criteria:

patients on antithrombotic/anticoagulant therapy patients suffering from bleeding disorders patients with esophageal and/or gastric varices patients previously treated for the same reason patients who were not able or refused to give informed written consent. vessels smaller than the knife inner diameter (1.2 mm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional coagulation of vessels
during study procedure accomplished under CO2-insufflation with the HK using SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD
Procedure: Coventional coagulation
In the conventional group, the haemostasis of vessels will be performed with the conventional coagulation technique under CO2 insufflation. First, submucosal fibres surrounding a blood vessel will be dissected and the vessel will be isolated. After, both sides of the isolated vessel will be coagulated using SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD until the blood vessel turns white and can be finally cut.
Experimental: Underwater coagulation of vessels
during study procedure carried out in the underwater setting with the HK using SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD
Procedure: Underwater coagulation
In the treatment group, the prophylactic haemostasis of vessels will be accomplished by the underwater coagulation technique. First, physiological solution will be instilled until there is no more air around the blood vessel. Then, the vessel will be coagulated using SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD until it turns white and, after the removal of all the physiological solution, can be finally cut.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: 12 months
Rate of patients with at least on vessel bleeding and requiring an adjunctive hemostasis
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delayed bleeding
Time Frame: 12 months
Rate of delayed bleeding per patient defined as clinical evidence of bleeding (hematemesis, hematochezia or melena or a decrease of hemoglobin concentration > 2g/dL) which required transfusion or endoscopic reintervention with hemostasis within 30 days of hospital discharge the endoscopic resection.
12 months
instrument exchanges
Time Frame: 12 months
Number of instrument exchanges per procedure
12 months
complications rate
Time Frame: 12 months
Other intra- and post-procedural complications rate per patient
12 months
Procedural time
Time Frame: 12 months
Mean procedural time
12 months
Patient-reported outcomes
Time Frame: 12 months
in terms of tolerability and post-procedural pain
12 months
variation of blood values
Time Frame: 12 months
Mean percentage variation of haematocrit, haemoglobin, C-reactive protein and white blood cells
12 months
intra-procedural bleeding
Time Frame: 12 months
Rate of intra-procedural bleeding per each vessel requiring the use of coagulation forceps
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Actual)

March 4, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CURRENT ID 3303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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