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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold EMR with adjuvant STSC to margins | Experimental | Standard cold EMR technique with adjuvant snare tip soft coagulation to defect margins |
|
| Cold EMR | Active Comparator | Standard Cold EMR resection technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Bourke, MBBS | Contact | 88905555 | michael@citywestgastro.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Michael Bourke, MBBS | Westmead Hospital (WSLHD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Endoscopy Unit | Recruiting | Westmead | New South Wales | 2145 | Australia |
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Randomised Controlled Trial
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Blinding
|
| Cold Snare Endoscopic Mucosal Resection | Procedure | Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare. |
|
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D000236 | Adenoma |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D012002 | Rectal Diseases |
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