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
- Diseases
- Colorectal cancer
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Campus Bio Medico Hospital Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.