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Completed

NCT Number: NCT07040020

This Randomized, Single-center Trial Aims to Evaluate the Advantages of Underwater ESD (U-ESD) in Comparison to the Conventional ESD (C-ESD).

Large nonpedunculated colorectal lesions are increasingly detected thanks to screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.

Nevertheless, colorectal ESD is burdened by technical difficulties and several adverse events affecting its outcomes. The adverse events could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs. Failure of endoscopic resection requiring surgery for benign lesions could affect patients' quality of life and increase healthcare systems' costs.

Thus, improving colorectal ESD outcomes is an important clinical and medico-economic objective. The underwater setting with saline has been already established as a better option than conventional CO2 insufflation for EMR of large colonic polyps. Moreover, use of the underwater approach for colorectal ESD has been increasingly reported with good results in the last few years. However, a randomized comparative trial between conventional and underwater colorectal ESD clarifying which should be the preferred approach is lacking.

Expected benefits are a decrease of adverse events and an increase of successful R0 resection rate of colorectal ESD.

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Key information

Conditions

Precancerous Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Humanitas Research Hospital

Rozzano, MI, 26900, Italy

About this study

The procedure in this study involves the application of underwater ESD for the resection of large nonpedunculated colorectal polyps.

Underwater ESD is a technique wherein the polyp is removed in an en bloc fashion. The procedure initiates with the identification and delineation of the polyp borders through careful endoscopic examination. Subsequently, after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed to lift the lesion. After that, subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection will be performed.

The clinical practice and technique of underwater ESD and conventional ESD performed during the course of the trial, will not be modified from standard clinical practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all patients ≥ 18 years of age with indication of ESD for large (>20mm) nonpedunculated colorectal polyps
  • patients who were able to give informed written consent

Exclusion criteria

  • Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
  • Suspicion of serrated/hyperplastic polyps by analysis of pit pattern (Kudo IIo)
  • Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
  • Polyp involving the anal verge
  • Polyp inside the ileo-cecal valvula

Treatment and study plan

Underwater ESD (U-ESD)

Procedure

Underwater ESD (U-ESD): after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out

Conventional ESD (C-ESD)

Other

Conventional ESD (C-ESD): under CO2 insufflation, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out.

Primary outcomes

  1. R0 resection

    Time frame: 24 hours

    Rate of successful and safe endoscopic resection defined as an R0 resection with no major adverse events (defined as any major procedure-related complication, such as delayed bleeding, intraprocedural and delayed perforation or post-electrocoagulation syndrome)

Secondary outcomes

  1. Compare

    Time frame: at 24 hours

    Compare the:

    • mean procedural time;
    • rate of en bloc resection;
    • rate of R0 resection;
    • rate of curative resection;
    • length of hospitalization;
    • rate of intraprocedural perforation;
    • rate of intraprocedural bleeding.

  2. delayed perforation

    Time frame: at 1 months

    To compare the proportion of delayed perforation between the two groups

  3. proportion of post-electrocoagulation syndrome

    Time frame: at Day 7

    To compare the proportion of post-electrocoagulation syndrome between the two groups

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Water-Assisted Versus Standard ESD for Large Nonpedunculated Colorectal Polyps: a Prospective Randomized Trial

Acronym: Wave-ESD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
Apr 21, 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.

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