Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas

Not Applicable

Not yet recruiting

• Conditions: Colonic Adenoma; Colonic Lesion; Colonic Neoplasms
• Interventions: Procedure: Traditional EMR; Procedure: the cold snare ("CO"), underwater technique ("W"), and the use of submucosal lift ("L") in both study arms

• Registration Number: NCT06217250
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

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 Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-22
• Study Start: 2024-04-15
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional EMR	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.
Underwater Cold EMR	the cold snare ("CO"), underwater technique ("W"), and the use of submucosal lift ("L") in both study arms	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.

Primary Outcome Measures

Name	Time	Method
Success rate of resection defined as absence of residual/recurrence in SC1 and/or SC2	at 6 and/or 12 months

Secondary Outcome Measures

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