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NCT07490574Completed

Trial of Underwater Versus Gas-Insufflation Colorectal Endoscopic Submucosal DisseEtion

Underwater Versus Conventional Endoscopic Submucosal Dissection For Colorectal Neoplasia: A Multicenter, Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 31 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
295 (actual)
First submitted
18 Mar 2026
Start date
1 Dec 2024
Primary completion date
1 Dec 2025
Lead sponsor
University of Roma La Sapienza
NCT number
NCT07490574

What you commit to

  • Study type: Interventional
  • Participants enrolled: 295
  • From 1 Dec 2024 to the primary completion date, 1 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Uninterrupted antithrombotic therapy

Other illness

  • Inflammatory bowel disease
  • Any clinical or lesion-related condition considered unsuitable for colorectal ESD by the treating endoscopist

Other

  • Known or suspected deep invasive neoplasia
  • Known coagulopathy

Who the study is looking for

  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Campus Bio Medico Hospital
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.