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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04138030




Registration number
NCT04138030
Ethics application status
Date submitted
20/10/2019
Date registered
24/10/2019
Date last updated
24/07/2024

Titles & IDs
Public title
Conventional Endoscopic Mucosal Resection Versus Cold Snare Endoscopic Mucosal Resection of Colonic Lateral Spreading Lesions - A Randomised Controlled Trial
Scientific title
Conventional Versus Cold Snare Endoscopic Mucosal Resection of Colonic Lateral Spreading Lesions - A Randomised Controlled Trial
Secondary ID [1] 0 0
(6114) 2019/ETH11826
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenoma Colon 0 0
Colon Adenoma 0 0
Colon Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Conventional Endoscopic Mucosal Resection
Treatment: Surgery - Cold Snare Endoscopic Mucosal Resection

Active comparator: Conventional Endoscopic Mucosal Resection - Conventional Endoscopic Mucosal Resection (EMR), if necessary, to 15-40mm laterally spreading adenomas.

Active comparator: Cold Snare Endoscopic Mucosal Resection - Cold Snare Endoscopic Mucosal Resection (EMR), if necessary, to 15-40mm laterally spreading adenomas.


Treatment: Surgery: Conventional Endoscopic Mucosal Resection
Use of injected chromogelofusine solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery

Treatment: Surgery: Cold Snare Endoscopic Mucosal Resection
Use of injected chromogelofusine solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete resection rate
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Adenoma recurrence rate
Timepoint [2] 0 0
4-6 months
Secondary outcome [1] 0 0
Time to perform polypectomy
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Intra-procedural and post-procedural complications
Timepoint [2] 0 0
30 days

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 LSL meeting to the following description:

* Localisation in the colon or rectum
* Benign adenomatous surface features (Kudo III / IV, 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 CRC
* Lesions involving the ileocaecal valve (ICV) or the anorectal junction (ARJ)

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
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
12/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2024
Sample size
Target
Accrual to date
Final
182
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
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, MBBS
Address 0 0
Western SLHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathleen Goodrick
Address 0 0
Country 0 0
Phone 0 0
88905555
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04138030