Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)

Study Overview
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Brief Summary
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Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading adenomas

Detailed Description
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Rationale: 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. Hypothesis: 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.

Official Title
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Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial

Conditions
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Colorectal Polyp, Colon Adenoma, Colon Cancer

Intervention / Treatment
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* Procedure: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation
* Procedure: Cold Snare Endoscopic Mucosal Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient undergoing colonoscopy who is older than 18 years of age, has a written consent for trial participation and has at least one laterally spreading lesion meeting the following description: Localisation in the colon or rectum Benign adenomatous surface features (Kudo III / IV, Japan NBI Expert Team (JNET) 2a) Granular or non-granular topography Paris classification 0-IIa/IIb +/- Is If present, sessile component may be no greater than 10mm in size. Polyp size ranging from 15 to 40mm Exclusion Criteria: Current use of antiplatelet (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines. Known bleeding disorder or coagulopathy. Pregnancy History of inflammatory bowel disease Previously attempted or otherwise non-lifting lesions Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3) or concurrent colorectal cancer Lesions involving the ileocaecal valve (ICV), appendiceal oriface or anorectal junction (ARJ)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold EMR with adjuvant STSC to margins<br>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<br>* 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.<br>|
| Active Comparator: Cold EMR<br>Standard Cold EMR resection technique | Procedure: Cold Snare Endoscopic Mucosal Resection<br>* Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete resection rate (CRR) | Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin) | 1 day | 
| Adenoma recurrence rate (ARR) | ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies) | 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-procedural and post-procedural complication rates | Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Polypectomy, Adenoma, Colorectal Cancer