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

NACompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

March 4, 2025

Study Completion Date

March 31, 2025

Conditions
Gastrointestinal DiseasesEndoscopic 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.

Trial Locations (1)

20089

Humanitas Research Hospital, Milan

All Listed Sponsors
lead

Istituto Clinico Humanitas

OTHER

NCT05804266 - A Randomized Comparison of UnderwateR Versus Regular Coagulation in Endoscopic Submucosal DissectioN and Third Space Endoscopy | Biotech Hunter | Biotech Hunter