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

Sponsor

Professor Michael Bourke (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT01369316

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps	Procedure: Circumferential Submucosal Incision Resection Procedure: Endoscopic Mucosal Resection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Resection for the Removal of Large Laterally Spreading Tumours and Sessile Polyps of the Colon

Anticipated Study Start Date :

Dec 30, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Circumferential Submucosal Incision Resection	Procedure: Circumferential Submucosal Incision Resection The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.
Active Comparator: 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.	Procedure: Endoscopic Mucosal Resection Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed

Arm

Intervention/Treatment

Experimental: Circumferential Submucosal Incision Resection

Procedure: Circumferential Submucosal Incision Resection

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

Active Comparator: 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.

Procedure: Endoscopic Mucosal Resection

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

Outcome Measures

Primary Outcome Measures

Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Hospital	Westmead	New South Wales	Australia	2145

Sponsors and Collaborators

Professor Michael Bourke

Investigators

Principal Investigator: Michael J Bourke, Westmead Hospital - Endoscopy Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District

ClinicalTrials.gov Identifier:

NCT01369316

Other Study ID Numbers:

EMR-002-CSI

First Posted:

Jun 8, 2011

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polyps

Colonic Polyps

Study Results

No Results Posted as of Mar 23, 2021