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

NCT ID: NCT01369316

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2020-03-09

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.

Conditions

Colonic Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Circumferential Submucosal Incision Resection

Group Type: EXPERIMENTAL

Circumferential Submucosal Incision Resection

Intervention Type: PROCEDURE

The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision 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.

Group Type: ACTIVE_COMPARATOR

Endoscopic Mucosal Resection

Intervention Type: PROCEDURE

Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed

Interventions

Circumferential Submucosal Incision Resection

The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.

Intervention Type: PROCEDURE

Endoscopic Mucosal Resection

Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Professor Michael Bourke

OTHER

Sponsor Role: lead

Responsible Party

Professor Michael Bourke

Dr Michael Bourke

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael J Bourke

Role: PRINCIPAL_INVESTIGATOR

Westmead Hospital - Endoscopy Unit

Locations

Westmead Hospital

Westmead, New South Wales, Australia

Countries

Australia

Other Identifiers

EMR-002-CSI

Identifier Type: -

Identifier Source: org_study_id