RecruitingNot ApplicableNCT07040020

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

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


Sponsor

Istituto Clinico Humanitas

Enrollment

122 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREUnderwater ESD (U-ESD)

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

OTHERConventional ESD (C-ESD)

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.


Locations(1)

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07040020