Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasia | — | UNRESOLVED | — |
| Colorectal Precancerous Lesions | — | UNRESOLVED | — |
| Colorectal Superficial Neoplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Gas-Assisted ESD (GESD) | Procedure | — | UNRESOLVED |
| Underwater ESD (UESD) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Underwater Endoscopic Submucosal Dissection (UESD)
- description
- 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.
- interventionNames
- Procedure: Underwater ESD (UESD)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Gas-Assisted Endoscopic Submucosal Dissection (GESD)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: 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
References
Publications (0)
Data not yet available