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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Western Sydney Local Health District
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01369316
First received: June 6, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 Intervention
Colonic Polyps
Procedure: Circumferential Submucosal Incision Resection
Procedure: Endoscopic Mucosal Resection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Western Sydney Local Health District:

Primary Outcome Measures:
  • Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369316

Contacts
Contact: Michael J Bourke 0298459779 westmeadendoscopyresearch@gmail.com
Contact: Rebecca Sonson 0298459779 bec2153@gmail.com

Locations
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael J Bourke    0298459779    westmeadendoscopyresearch@gmail.com   
Contact: Rebecca Sonson    0298459779    bec2153@gmail.com   
Principal Investigator: Michael J Bourke         
Principal Investigator: Farzan Fartash         
Sub-Investigator: Stephen J Williams         
Sub-Investigator: Alan Moss         
Sponsors and Collaborators
Professor Michael Bourke
Investigators
Principal Investigator: Michael J Bourke Westmead Hospital - Endoscopy Unit
  More Information

No publications provided

Responsible Party: Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01369316     History of Changes
Other Study ID Numbers: EMR-002-CSI
Study First Received: June 6, 2011
Last Updated: June 30, 2014
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 19, 2014