Skip to main content
OpenTrials
Completed

NCT Number: NCT07490574

Trial of Underwater Versus Gas-Insufflation Colorectal Endoscopic Submucosal DisseEtion

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Bio Medico Hospital

Rome, RM, 00100, Italy

About this study

Colorectal ESD is an established organ-preserving technique for the en bloc resection of superficial colorectal neoplasia, particularly when conventional endoscopic mucosal resection is unlikely to achieve complete single-piece excision. However, colorectal ESD is technically demanding because of the thin colonic wall, unstable scope position, narrow submucosal space, intraprocedural bleeding, smoke generation, and difficulty in maintaining a stable dissection plane.

Underwater ESD has emerged as a modified operative environment in which luminal insufflation is discontinued and the target segment is immersed in saline. Saline immersion may improve visualization of the submucosal layer and of submucosal vessels, limit smoke persistence in the operative field, and facilitate more stable dissection. Although initial retrospective and comparative experiences have suggested procedural advantages of underwater ESD, high-quality randomized comparative data remain limited, particularly in Western multicenter practice.

This study was therefore designed as a prospective multicenter randomized trial across Italian tertiary referral centers to compare underwater ESD with conventional gas-assisted ESD for colorectal neoplasia referred for ESD. Patients were allocated 1:1 to either UESD or GESD. The primary endpoint was en bloc resection. Secondary endpoints included R0 resection, procedural time, dissection speed, intraprocedural bleeding, need for hemostatic forceps, smoke interference, vessel visualization, cutting-plane visualization, post-procedural pain, post-ESD coagulation syndrome, perforation, and delayed bleeding. The technical conduct of ESD apart from the assigned luminal environment was left to expert operator discretion in order to preserve real-world tertiary-center practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Underwater ESD (UESD)

Procedure

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

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.

Primary outcomes

  1. En bloc resection rate

    Time frame: During the index procedure

    Proportion of lesions resected in a single specimen.

Secondary outcomes

  1. R0 resection rate

    Time frame: During index procedure and histopathological assessment within 30 days

    Proportion of lesions resected en bloc with histologically negative lateral and vertical margins.

  2. Procedural time

    Time frame: During the index procedure

    Time from submucosal injection to completion of lesion dissection.

  3. Dissection speed

    Time frame: During the index procedure

    Rate of dissection calculated by dividing specimen area by dissection time.

  4. Intraprocedural bleeding rate

    Time frame: During the index procedure

    Proportion of procedures with any bleeding occurring during ESD.

  5. Use of hemostatic forceps

    Time frame: During the index procedure

    Proportion of procedures requiring coagulation forceps for active bleeding or prophylactic vessel coagulation.

  6. Smoke interference

    Time frame: During the index procedure

    Proportion of procedures in which electrocautery-generated fumes/particulate matter impaired visualization and required repeated lens irrigation or temporary withdrawal.

  7. Vessel visualization score

    Time frame: Immediately after the index procedure

    Operator-reported 5-point Likert score assessing clarity of identification of submucosal vessels during dissection. Lower scores indicate better visualization.

  8. Cutting-plane visualization score

    Time frame: Immediately after the index procedure

    Operator-reported 5-point Likert score assessing clarity of the dissection interface between submucosa and muscularis propria. Lower scores indicate better visualization.

  9. Post-procedural abdominal pain

    Time frame: 15, 30, and 60 minutes after the procedure

    Post-procedural pain assessed on a 0-3 numerical scale by nursing staff.

  10. Post-ESD coagulation syndrome (PECS)

    Time frame: Within 7 days

    Proportion of patients with abdominal distension or pain at the resection site associated with fever or inflammatory response in the absence of documented perforation.

  11. Perforation rate

    Time frame: From procedure to 30 days

    Proportion of intraprocedural or delayed perforations.

  12. Delayed bleeding rate

    Time frame: From procedure to 30 days

    Proportion of patients with clinically overt post-procedural bleeding or hemoglobin decrease >2 g/dL without another source.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Campus Bio-Medico University

Registry information

Official study title

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

Acronym: TIDE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.