Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps (CSIEMR)

Professor Michael Bourke

Status: Withdrawn

Conditions: Colonic Polyps

Treatments: Procedure: Endoscopic Mucosal Resection; Procedure: Circumferential Submucosal Incision Resection

Study type: Interventional

Funder types: Other

Identifiers

NCT01369316

EMR-002-CSI

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Circumferential Submucosal Incision Resection

Experimental group

Treatment:

Procedure: Circumferential Submucosal Incision Resection

Endoscopic Mucosal Resection

Active Comparator group

Description:

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.

Treatment:

Procedure: Endoscopic Mucosal Resection