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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05041478




Registration number
NCT05041478
Ethics application status
Date submitted
2/09/2021
Date registered
13/09/2021
Date last updated
13/09/2021

Titles & IDs
Public title
Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)
Scientific title
Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
Secondary ID [1] 0 0
ETH11029
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Polyp 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 - 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.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete resection rate (CRR) - Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Adenoma recurrence rate (ARR) - ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)
Timepoint [2] 0 0
4-6 months
Secondary outcome [1] 0 0
Intra-procedural and post-procedural complication rates - Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
Timepoint [1] 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 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
Minimum age
18 Years
Maximum age
No limit
Gender
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 colorectal cancer

- Lesions involving the ileocaecal valve (ICV), appendiceal oriface or 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
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
Trial website
https://clinicaltrials.gov/show/NCT05041478
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, MBBS
Address 0 0
Westmead Hospital (WSLHD)
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
Kathleen.goodrick@health.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05041478