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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02196649




Registration number
NCT02196649
Ethics application status
Date submitted
17/07/2014
Date registered
22/07/2014
Date last updated
29/06/2023

Titles & IDs
Public title
Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial
Scientific title
Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.
Secondary ID [1] 0 0
HREC2014/5/4.2(3971)
Universal Trial Number (UTN)
Trial acronym
CuRB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 0 0
Condition category
Condition code
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
Experimental: Endoscopic Clipping - Participants randomised to the arm will receive endoscopic clips to their defect following EMR.

No intervention: No Endoscopic Clipping - These participants will receive standard of care practice only.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post-Procedural Bleeding
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Safety success
Timepoint [1] 0 0
18 months

Eligibility
Key inclusion criteria
* Can give informed consent to trial participation
* Lesion size greater than 20 mm
* Lesion proximal to and inclusive of mid transverse colon
* Laterally spreading or sessile polyp morphology
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous resection or attempted resection of lesion
* Clip deployed prior to the completion of the EMR
* Major intraprocedural bleeding not treatable by coagulation
* Endoscopic appearance of invasive malignancy
* Age less than 18 years
* Pregnancy
* Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
* Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
* American Society of Anesthesiology (ASA) Grade IV-V

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2021
Sample size
Target
Accrual to date
Final
230
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - 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
Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.
Trial website
https://clinicaltrials.gov/study/NCT02196649
Trial related presentations / publications
Gupta S, Sidhu M, Shahidi N, Vosko S, McKay O, Bahin FF, Zahid S, Whitfield A, Byth K, Brown G, Lee EYT, Williams SJ, Burgess NG, Bourke MJ. Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):152-160. doi: 10.1016/S2468-1253(21)00384-8. Epub 2021 Nov 18. Erratum In: Lancet Gastroenterol Hepatol. 2022 Feb;7(2):e2. doi: 10.1016/S2468-1253(21)00480-5.
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Western Sydney Local Health District
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/NCT02196649