NCT07040020

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Precancerous Lesions

Interventions

Type	Name	Description
PROCEDURE	Underwater 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
OTHER	Conventional 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.

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: Italy