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

NCT05804266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Gastrointestinal Diseases
  • Endoscopic Surgery

Interventions

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.

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.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2025-03-04
Completion
2025-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05804266 on ClinicalTrials.gov