Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas (COWL)

April 16, 2024 updated by: Istituto Clinico Humanitas

Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas (>20 mm): the "CO.W.L." Prospective Randomized Trial

This randomized, multi-center trial aims to evaluate the advantages of underwater cold endoscopic mucosal resection technique (CS-EMR) in comparison to the conventional endoscopic mucosal resection technique (EMR) for laterally spreading colorectal lesions exceeding 20 mm in size. More precisely, our hypothesis posits that underwater cold EMR is non-inferior to conventional EMR in terms of recurrence rates, resection completeness and safety.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Endoscopic mucosal resection stands as one of the most commonly employed techniques for the removal of gastrointestinal lesions, particularly within the colon. "Piece-meal" endoscopic mucosal resection is the preferred approach for large colonic polyps without signs of deep infiltration. This method consists of the removal of lesions in multiple fragments.

The conventional procedure starts with the initial submucosal infiltration of the submucosal layer using a physiological solution and methylene blue, forming a cushion that facilitates tissue transection with the assistance of a diathermic snare. The goal is to remove the lesions in larger fragments whenever possible.

In contrast, the "cold" procedure, employs a specialized snare that enables tissue transection without the need for electrical current. This approach yields the same outcome as the conventional procedure but offers the advantage of reducing the risks associated with the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • all patients ≥ 18 years of age undergoing colonoscopy for any indication (screening, anaemia, surveillance)
  • patients who were able to give informed written consent.

Exclusion criteria:

  • lesions suspicious for submucosal invasion (e.g. Kudo V or Paris 0-IIa-IIc with nongranular surface).
  • lesions with large (>10 mm) Paris 0-Is component that could compromise the nodular en-bloc resection and increase risk of submucosal invasion.
  • suspected sessile serrated adenomas (SSAs) according to traditional features such as adherent surface mucus, cloud-like surface, interruption of mucosal vessels, Kudo II-o pit pattern.
  • pedunculated polyps
  • active/quiescent colitis
  • patients with other lesions resected by hot snare during the same procedure.
  • rectal lesions
  • residual or recurrent adenoma after endoscopic mucosal resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional EMR
Conventional EMR with thermal ablation of resection margins: initial submucosal injection of saline and methylene blue and subsequent piecemeal resection with 10- or 15-mm diathermic snare with subsequent thermal ablation of resection margins with snare tip soft coagulation.
Procedure: Traditional EMR
Conventional EMR with thermal ablation of resection margins: initial submucosal injection of saline and methylene blue and subsequent piecemeal resection with 10- or 15-mm diathermic snare with subsequent thermal ablation of resection margins with snare tip soft coagulation.Nevertheless, this technique is associated with the emergence of serious adverse events (SAEs), including delayed bleeding (PPB), electrocautery-induced post-polipectomy syndrome (PPS), and perforation(4).
Other Names:
  • Endoscopic Mucosal Resection
Experimental: Underwater Cold EMR
Underwater Cold EMR (CS-EMR): after filling the lumen with water, initial submucosal injection of saline and methylene blue and subsequent piece-meal resection carried out with dedicated cold snare.
Procedure: the cold snare ("CO"), underwater technique ("W"), and the use of submucosal lift ("L") in both study arms
The "cold-EMR" technique, as opposed to the conventional approach, employs a specialized snare that enables tissue transection without the need for electrical current, particularly in appropriately selected lesions. This approach yields the same efficacy outcome as the conventional procedure but offers the advantage of reducing the risks associated with polypectomy, which are often secondary to the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination. Furthermore, the use of underwater setting, as demonstrated for hot EMR, could improve the effectiveness of cold-EMR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate of resection defined as absence of residual/recurrence in SC1 and/or SC2
Time Frame: at 6 and/or 12 months
at 6 and/or 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of intraprocedural adverse events such as bleeding or perforation
Time Frame: 2 years
Defined as any procedure-related complication that compromises the completeness of the procedure and/or results in unplanned hospitalization of the patient
2 years
Rate of delayed bleeding of the patient
Time Frame: 2 years
2 years
Rate of post-polipectomy syndrome
Time Frame: 2 years
2 years
Rate of delayed perforation
Time Frame: 2 years
2 years
Avarage time of procedure and polyp resection time
Time Frame: 2 years
2 years
technical success
Time Frame: 2 years
defined by the complete resection of polyp
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COWL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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