An interventional study of Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation and Cold Snare Endoscopic Mucosal Resection in Colorectal Polyp, Colon Adenoma and Colon Cancer, sponsored by Western Sydney Local Health District. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Western Sydney Local Health District · Not applicable, Interventional, and Treatment
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
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 300 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
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Exclusion Criteria:
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
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. Following this defect margins are treated with electrocautery to create a rim of ablated tissue.
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)
Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)
Time frame: 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)
Time frame: 4-6 months
Intra-procedural and post-procedural complication rates
Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
Time frame: 30 days
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Western Sydney Local Health District