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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/NCT04138030




Registration number
NCT04138030
Ethics application status
Date submitted
20/10/2019
Date registered
24/10/2019
Date last updated
29/06/2023

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
27/10/2024
Actual
Sample size
Target
600
Accrual to date
Final
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
Comparing the complete resection rate and subsequent adenoma recurrence rate at surveillance
colonoscopy of 15-40mm laterally spreading adenomas for conventional EMR vs. cold snare EMR.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04138030
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04138030