Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps (CSIEMR)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Muscosal 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 |
- 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 Muscosal 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 |
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| Contact: Michael J Bourke | 0298459779 | westmeadendoscopyresearch@gmail.com |
| Contact: Rebecca Sonson | 0298459779 | bec2153@gmail.com |
| 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 | |
| Principal Investigator: | Michael J Bourke | Westmead Hospital - Endoscopy Unit |
More Information
No publications provided
| Responsible Party: | Professor Michael Bourke, Dr Michael Bourke, South West 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 12, 2013 |
| 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 June 18, 2013