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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Universal Trial Number (UTN)
Trial acronym
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)

Study type
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

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

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

- Adenoma size greater than 20 mm
Minimum age
18 Years
Maximum age
95 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Age less than 18

- Previous resection or attempted resection of target adenoma lesion

- Pregnant patients

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Professor Michael Bourke

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Michael J Bourke
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