200
Participants
Start Date
November 25, 2023
Primary Completion Date
October 10, 2025
Study Completion Date
September 30, 2026
Cold endoscopic mucosal resection
3-4 ml of solution is injected into the submucosal layer under the formation. The formation with the surrounding mucous membrane (at least 1 mm from the edge of the formation) is captured with a specialized or standard polypectomy loop available to the operator (depending on the randomization result). The formation is removed by mechanical cutting without using electric current.
Hot endoscopic mucosal resection
"3-4 ml of solution is injected into the submucosal layer under the formation. The formation with the surrounding mucous membrane (at least 1 mm from the edge of the formation) is captured with a specialized or standard diathermic polypectomy loop available to the operator (depending on the randomization result). The formation is removed using electric current in the Endocat mode (or its analogue, providing alternating cutting and coagulation under the control of a processor built into the electrical unit).~After the formation is removed, the resection site is examined in white light, then virtual chromoscopy (NBI), and then an examination with magnification. The examination results are recorded in the scientific protocol separately, and are assessed as a whole. The criteria for visual removal of the formation within healthy tissues are the absence of visible fragments of the formation. The time of complete cessation of capillary bleeding is recorded."
RECRUITING
Evgeny Gorbachev, Moscow
Pirogov Russian National Research Medical University
OTHER