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

Colonic Polyps Clinical Trial

— CSIEMR  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01369316
• Other study ID #: EMR-002-CSI
• Status: Withdrawn
• Phase: N/A
• Start date: December 30, 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps

Intervention

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

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)		3 months