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

This study is not yet open for participant recruitment.
Verified November 2017 by Professor Michael Bourke, Western Sydney Local Health District
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369316
First Posted: June 8, 2011
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District
  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
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

Resource links provided by NLM:


Further study details as provided by Professor Michael Bourke, Western Sydney Local Health District:

Primary Outcome Measures:
  • Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates) [ Time Frame: 3 months ]

Estimated Enrollment: 160
Anticipated Study Start Date: December 30, 2017
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2020 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369316


Contacts
Contact: Michael J Bourke 0298459779 ace.westmead@gmail.com
Contact: Kathleen Goodrick 0288909779 kathleen.goodrick@health.nsw.gov.au

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

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
First Submitted: June 6, 2011
First Posted: June 8, 2011
Last Update Posted: November 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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