Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-28 @ 11:15 AM
Study NCT ID:
NCT06217250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas (>20 mm): the "CO.W.L." Prospective Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COWL
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: