Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
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|ClinicalTrials.gov Identifier: NCT05041478|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2021
Last Update Posted : September 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Polyp Colon Adenoma Colon Cancer||Procedure: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation Procedure: Cold Snare Endoscopic Mucosal Resection||Not Applicable|
Conventional EMR is well-established for the resection of lateral-spreading adenomas and has been shown to be highly efficacious with adjuvant STSC. Cauterisation-related complications occur relatively frequently and while endoscopically treatable, still carry morbidity not seen in current cold snare polypectomy data.
Cold snare polypectomy has an excellent safety profile for smaller polyps, without cauterisation-related adverse events. Limited data on cold EMR for large adenomatous laterally-spreading lesions shows minimal complications. Efficacy, however, is yet to be evaluated in prospective randomised trials. Observational data demonstrates recurrence rates exceeding conventional EMR. Since STSC causes significant reduction in recurrence in conventional EMR, the safety and efficacy of this adjuvant technique, when compared to isolated cold snare EMR, has theoretical advantages in both safety and efficacy.
The safety and efficacy of these two techniques will therefore be compared in a randomised controlled trial.
Cold snare EMR of 15-40mm lateral-spreading adenomas with adjuvant STSC is expected to be superior regarding complete resection and adenoma recurrence rates as compared to cold snare EMR.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised Controlled Trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial|
|Estimated Study Start Date :||January 1, 2022|
|Estimated Primary Completion Date :||January 1, 2025|
|Estimated Study Completion Date :||June 1, 2025|
Experimental: Cold EMR with adjuvant STSC to margins
Standard cold EMR technique with adjuvant snare tip soft coagulation to defect margins
Procedure: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation
Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare. Following this defect margins are treated with electrocautery to create a rim of ablated tissue.
Active Comparator: Cold EMR
Standard Cold EMR resection technique
Procedure: Cold Snare Endoscopic Mucosal Resection
Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.
- Complete resection rate (CRR) [ Time Frame: 1 day ]Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)
- Adenoma recurrence rate (ARR) [ Time Frame: 4-6 months ]ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)
- Intra-procedural and post-procedural complication rates [ Time Frame: 30 days ]Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041478
|Contact: Kathleen Goodrick||88905555||Kathleen.firstname.lastname@example.org|
|Australia, New South Wales|
|Westmead Endoscopy Unit|
|Westmead, New South Wales, Australia, 2145|
|Principal Investigator:||Michael Bourke, MBBS||Westmead Hospital (WSLHD)|