Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01369316




Registration number
NCT01369316
Ethics application status
Date submitted
6/06/2011
Date registered
8/06/2011
Date last updated
3/07/2023

Titles & IDs
Public title
Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps
Scientific 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
Secondary ID [1] 0 0
EMR-002-CSI
Universal Trial Number (UTN)
Trial acronym
CSIEMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Circumferential Submucosal Incision Resection
Treatment: Surgery - Endoscopic Mucosal Resection

Experimental: Circumferential Submucosal Incision 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.


Treatment: Surgery: Circumferential Submucosal Incision Resection
The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.

Treatment: Surgery: Endoscopic Mucosal Resection
Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)
Timepoint [1] 0 0
3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age less than 18
* Previous resection or attempted resection of target adenoma lesion
* Pregnant patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/12/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01369316
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke
Address 0 0
Westmead Hospital - Endoscopy Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01369316