Trial of Underwater Versus Gas-Insufflation Colorectal Endoscopic Submucosal DisseEtion

NCT07490574 | Completed

• 1 other identifier: TIDE
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Neoplasia; Colorectal Superficial Neoplasia; Colorectal Precancerous Lesions

Keywords

colorectal ESD; underwater ESD; endoscopic submucosal dissection; colorectal neoplasia; en bloc resection

Outcome Measures

Primary Outcomes (1)

• En bloc resection rate

  Proportion of lesions resected in a single specimen.

  During the index procedure

Secondary Outcomes (12)

• R0 resection rate

  During index procedure and histopathological assessment within 30 days

• Procedural time

  During the index procedure

• Dissection speed

  During the index procedure

• Intraprocedural bleeding rate

  During the index procedure

• Use of hemostatic forceps

  During the index procedure

Study Arms (2)

Underwater Endoscopic Submucosal Dissection (UESD)

EXPERIMENTAL

Underwater endoscopic submucosal dissection was performed after placement of the lesion on the anti-gravity side whenever feasible, discontinuation of luminal insufflation, and filling of the target colonic segment with saline solution to obtain stable immersion of the operative field. After immersion, mucosal incision and submucosal dissection were completed according to standard ESD principles, using either a conventional stepwise or tunnel-based strategy according to lesion characteristics and operator preference. Only saline solution was standardized across centers; device selection, generator settings, and ancillary maneuvers were otherwise left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps.

Procedure: Underwater ESD (UESD)

Conventional Gas-Assisted Endoscopic Submucosal Dissection (GESD)

ACTIVE COMPARATOR

Conventional colorectal ESD was performed under gas insufflation according to standard practice at each participating center. Mucosal incision and submucosal dissection were carried out according to standard ESD technique. Device selection, generator settings, and technical dissection strategy were left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps.

Procedure: Conventional Gas-Assisted ESD (GESD)

Interventions

Underwater ESD (UESD) PROCEDURE

Underwater ESD (UESD) performed under saline immersion with luminal insufflation turned off.

Underwater Endoscopic Submucosal Dissection (UESD)

Conventional Gas-Assisted ESD (GESD) PROCEDURE

Conventional colorectal ESD was performed under gas insufflation according to standard practice at each participating center. Mucosal incision and submucosal dissection were carried out according to standard ESD technique. Device selection, generator settings, and technical dissection strategy were left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps.

Conventional Gas-Assisted Endoscopic Submucosal Dissection (GESD)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older
• Colorectal neoplastic lesion referred for endoscopic submucosal dissection
• Lesion considered amenable to en bloc endoscopic resection by ESD according to expert pre-procedural endoscopic assessment
• Written informed consent provided

You may not qualify if:

• Known or suspected deep invasive neoplasia
• Inflammatory bowel disease
• Uninterrupted antithrombotic therapy
• Known coagulopathy
• Any clinical or lesion-related condition considered unsuitable for colorectal ESD by the treating endoscopist

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Campus Bio-Medico University: collaborator

Study Sites (1)

Campus Bio Medico Hospital

Rome, RM, 00100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after the publication, for 5 years at least

Locations

IT (1)