Trial of Underwater Versus Gas-Insufflation Colorectal Endoscopic Submucosal DisseEtion

Colorectal endoscopic submucosal dissection (ESD) enables en bloc resection of large superficial colorectal neoplasia but remains technically demanding and may be limited by suboptimal visualization, intraprocedural bleeding, smoke accumulation, and prolonged procedural time. Underwater ESD (UESD), performed under saline immersion rather than gas insufflation, has been proposed as a strategy to improve the operative field and facilitate submucosal dissection. This prospective, multicenter, open-label, randomized controlled trial was designed to compare UESD with conventional gas-assisted ESD (GESD) for colorectal neoplasia referred for ESD across Italian tertiary centers. The primary objective was to assess non-inferiority of UESD versus GESD in terms of en bloc resection. Secondary objectives included comparison of histological resection quality, procedural efficiency, intraprocedural events, procedural field visualization, and post-procedural adverse events.

NCT Number	NCT07490574
Lead Sponsor	University of Roma La Sapienza Collaborators: Campus Bio-Medico University
Conditions	Colorectal Neoplasia, Colorectal Superficial Neoplasia, Colorectal Precancerous Lesions
Enrollment	295 participants
Start Date	2024-12-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2026-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-31