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Trial of Underwater Versus Gas-Insufflation Colorectal Endoscopic Submucosal DisseEtion

NCT07490574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2026-03-31

No results posted yet for this study

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

Interventions

PROCEDURE

Underwater ESD (UESD)

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

PROCEDURE

Conventional Gas-Assisted ESD (GESD)

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.

Sponsors & Collaborators

  • Campus Bio-Medico University

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-01
Completion
2026-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07490574 on ClinicalTrials.gov