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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05041478
Registration number
NCT05041478
Ethics application status
Date submitted
2/09/2021
Date registered
13/09/2021
Date last updated
29/06/2023
Titles & IDs
Public title
Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
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Scientific title
Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
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Secondary ID [1]
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ETH11029
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Polyp
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Colon Adenoma
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Colon Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation
Treatment: Surgery - Cold Snare Endoscopic Mucosal Resection
Experimental: Cold EMR with adjuvant STSC to margins - Standard cold EMR technique with adjuvant snare tip soft coagulation to defect margins
Active Comparator: Cold EMR - Standard Cold EMR resection technique
Treatment: Surgery: Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation
Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare. Following this defect margins are treated with electrocautery to create a rim of ablated tissue.
Treatment: Surgery: Cold Snare Endoscopic Mucosal Resection
Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Complete resection rate (CRR)
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Assessment method [1]
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Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)
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Timepoint [1]
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1 day
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Primary outcome [2]
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Adenoma recurrence rate (ARR)
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Assessment method [2]
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ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)
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Timepoint [2]
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4-6 months
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Secondary outcome [1]
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Intra-procedural and post-procedural complication rates
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Assessment method [1]
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Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
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Timepoint [1]
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30 days
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Eligibility
Key inclusion criteria
- Any patient undergoing colonoscopy who is older than 18 years of age, has a written
consent for trial participation and has at least one laterally spreading lesion
meeting the following description:
- Localisation in the colon or rectum
- Benign adenomatous surface features (Kudo III / IV, Japan NBI Expert Team (JNET) 2a)
- Granular or non-granular topography
- Paris classification 0-IIa/IIb +/- Is
- If present, sessile component may be no greater than 10mm in size.
- Polyp size ranging from 15 to 40mm
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current use of antiplatelet (excluding aspirin) or anticoagulants which have not
appropriately been interrupted according to the guidelines.
- Known bleeding disorder or coagulopathy.
- Pregnancy
- History of inflammatory bowel disease
- Previously attempted or otherwise non-lifting lesions
- Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3) or
concurrent colorectal cancer
- Lesions involving the ileocaecal valve (ICV), appendiceal oriface or anorectal
junction (ARJ)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/11/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2028
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Endoscopy Unit - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
Western Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold
snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading
adenomas
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05041478
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Bourke, MBBS
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Address
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Westmead Hospital (WSLHD)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kathleen Goodrick
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Address
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Country
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Phone
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88905555
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05041478
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