Actively Recruiting
Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
Led by Western Sydney Local Health District · Updated on 2025-03-27
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates cold snare endoscopic mucosal resection (EMR) techniques for removing 15-40mm lateral-spreading adenomas in the colon or rectum. It compares standard cold snare EMR with cold snare EMR combined with adjuvant margin snare tip soft coagulation (STSC). The study aims to assess whether adding STSC improves complete resection rates and reduces adenoma recurrence, addressing safety concerns related to cauterisation complications in conventional EMR. Participants undergo a colonoscopy where the lesion is raised using injected chromogelofusine solution. In one group, the lesion is removed using a stiff thin-wired snare followed by electrocautery treatment of the defect margins with STSC to ablate tissue. The other group receives the same removal procedure without the adjuvant thermal therapy. This randomized controlled trial evaluates these two procedures to compare their safety and effectiveness. During the study, researchers measure the complete resection rate one day after the procedure and adenoma recurrence rates at 4 to 6 months. They also monitor intra-procedural and post-procedural complications for 30 days. Participants provide written consent and are followed through trial visits, allowing detailed assessment of outcomes related to polyp removal and recovery. The study is sponsored by Western Sydney Local Health District and runs until October 2028.
CONDITIONS
Brief Title
Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any patient undergoing colonoscopy who is 18 years or older
- Written consent for trial participation
- At least one lateral spreading lesion located in the colon or rectum
- Lesion must have benign adenomatous surface features (Kudo III / IV, JNET 2a)
- Granular or non-granular topography
- Paris classification 0-IIa/IIb +/- Is
- Sessile component, if present, no greater than 10mm in size
- Polyp size ranging from 15 to 40mm
You will not qualify if you...
- Current use of antiplatelet (excluding aspirin) or anticoagulants not properly interrupted per guidelines
- Known bleeding disorder or coagulopathy
- Pregnancy
- History of inflammatory bowel disease
- Previously attempted or non-lifting lesions
- Endoscopic features suggesting submucosal invasion or concurrent colorectal cancer
- Lesions involving the ileocaecal valve, appendiceal orifice, or anorectal junction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cold snare endoscopic mucosal resection with or without adjuvant snare tip soft coagulation to the resection margins.
1 procedure visit (in-person)
Duration - 4 to 6 months
Participants are monitored for adenoma recurrence and any complications after the procedure.
1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Westmead Endoscopy Unit
Westmead, New South Wales, Australia, 2145
Actively Recruiting
Research Team
M
Michael Bourke, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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