Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Bourke, MBBS
- Phone Number: 88905555
- Email: michael@citywestgastro.com.au
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Recruiting
- Westmead Endoscopy Unit
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Contact:
- Clarence Kerrison, MBBS
- Phone Number: 88905555
- Email: clarence.kerrison@health.nsw.gov.au
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cold EMR with adjuvant STSC to margins
Standard cold EMR technique with adjuvant snare tip soft coagulation to defect margins
|
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
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Use of injected chromogelofusine solution to raise a lesion prior to polypectomy.
Lesion then removed with a stiff thin-wired snare.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete resection rate (CRR)
Time Frame: 1 day
|
Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)
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1 day
|
|
Adenoma recurrence rate (ARR)
Time Frame: 4-6 months
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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
Time Frame: 30 days
|
Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Bourke, MBBS, Westmead Hospital (WSLHD)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETH11029
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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