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

NCT07040020 | Completed

• 1 other identifier: ID 4139 Wave-ESD
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Precancerous Lesions

Keywords

esd; large nonpedunculated colorectal polyps

Outcome Measures

Primary Outcomes (1)

• R0 resection

  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)

  24 hours

Secondary Outcomes (3)

• Compare

  at 24 hours

• delayed perforation

  at 1 months

• proportion of post-electrocoagulation syndrome

  at Day 7

Study Arms (2)

Conventional ESD

ACTIVE COMPARATOR

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

Other: Conventional ESD (C-ESD)

Underwater ESD (U-ESD)

EXPERIMENTAL

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.

Procedure: Underwater ESD (U-ESD)

Interventions

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

Underwater ESD (U-ESD)

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.

Conventional ESD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, 26900, Italy

Location

Related Publications (17)

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  PMID: 38383144 RESULT

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: June 26, 2025
• Study Start: March 31, 2025
• Primary Completion: March 26, 2026
• Study Completion: March 26, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

IT (1)