Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps

Not Applicable

Withdrawn

• Conditions: Colonic Polyps
• Interventions: Procedure: Circumferential Submucosal Incision Resection; Procedure: Endoscopic Mucosal Resection

• Registration Number: NCT01369316
• Lead Sponsor: Professor Michael Bourke

Brief Summary

That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon.

Detailed Description

The investigators have recently developed a new, and the investigators believe safer and more effective technique for endoscopic mucosal resection (EMR). Utilising the new method the investigators make small cuts around the polyp to isolate it. Subsequently the Gelofusine solution is injected beneath the polyp and provides greater elevation. This allows us to improve the chance of removal of the entire polyp with one attempt in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. Our team has recently completed an animal study comparing our newly developed technique to conventional EMR. The investigators have found significant improvements in our ability to completely remove the polyp in one attempt. There have also been recent studies overseas that have shown this new technique to be quite effective.

Study Timeline

• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Study Start: 2020-03-09
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Can give informed consent to trial participation
• Age greater than 18
• Adenomas that have not have previously been attempted for resection (i.e. naïve lesions)
• Adenoma size greater than 20 mm

Exclusion Criteria

• Age less than 18
• Previous resection or attempted resection of target adenoma lesion
• Pregnant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circumferential Submucosal Incision Resection	Circumferential Submucosal Incision Resection	-
Endoscopic Mucosal Resection	Endoscopic Mucosal Resection	Patients randomised into this arm will receive the conventional treatment Endoscopic Mucosal Resection in which the sessile lesion is injected and snared by piecemeal technique.

Primary Outcome Measures

Name	Time	Method
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)	3 months

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia