Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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)
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT05041478
Intervention or treatment
PROCEDURE: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation
PROCEDURE: Cold Snare Endoscopic Mucosal Resection
Conditions
- Colorectal Polyp
- Colon Adenoma
- Colon Cancer
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Research sites nearby
Closest Location:
Westmead Endoscopy Unit
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Westmead Endoscopy Unit
Westmead, New South Wales, Australia
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Who is running the clinical trial?
Western Sydney Local Health District
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Cold EMR with adjuvant STSC to margins
| Procedure: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation |
ACTIVE_COMPARATOR: Cold EMR
| Procedure: Cold Snare Endoscopic Mucosal Resection |
What is the study measuring?
Primary Outcome
| 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
| 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 |
References
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