Back to resultsCircumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps (CSIEMR)
Primary Purpose
Colonic Polyps
Status
Withdrawn
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Circumferential Submucosal Incision Resection
Endoscopic Mucosal Resection
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyps
Eligibility 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
Sites / Locations
- Westmead Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Circumferential Submucosal Incision Resection
Endoscopic Mucosal Resection
Arm Description
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.
Outcomes
Primary Outcome Measures
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01369316
Brief Title
Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
study abandoned
Study Start Date
December 30, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Michael Bourke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Circumferential Submucosal Incision Resection
Arm Type
Experimental
Arm Title
Endoscopic Mucosal Resection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Circumferential Submucosal Incision Resection
Intervention Description
The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Mucosal Resection
Intervention Description
Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed
Primary Outcome Measure Information:
Title
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Bourke
Organizational Affiliation
Westmead Hospital - Endoscopy Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps
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