Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001119785
Ethics application status
Approved
Date submitted
21/12/2021
Date registered
15/08/2022
Date last updated
15/08/2022
Date data sharing statement initially provided
15/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the safety of routine snare tip soft coagulation (STSC) in patients undergoing endoscopic mucosal resection for large polyps during colonoscopy
Scientific title
Assessing the safety of routine snare tip soft coagulation (STSC) in patients undergoing endoscopic mucosal resection for large polyps during colonoscopy
Secondary ID [1] 305824 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic polyp 324338 0
Condition category
Condition code
Cancer 321829 321829 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are assessing whether additional snare tip soft coagulation (STSC) therapy applied to the resection margins of a defect following piecemeal removal of a large colonic polyp without electrocautery will reduce the risk of polyp recurrence. The safety profile of this intervention will also be assessed (although it has been found to be safe in other large multicentre studies).

STSC will be performed using the wire tip of a polypectomy snare. The tip is positioned 1-2mm beyond the end of the snare sheath and thermal ablation is applied to the edges of the polypectomy defect margins using this tip with the assistance of a microprocessor-controlled generator (SOFT COAG mode, 80W Effect 4, ERBE Electromedizin, Tubingen, Germany). The aim will be to create a 2mm circumferential rim of completely ablated tissue around the defect. This typically requires up to 5 minutes of additional procedure time and will be delivered to patients streamlined to the "intervention" arm of the study. Photodocumentation will be required following STSC.

This will be performed by gastroenterologists who have experience in both resection of large polyps and application of STSC.
Intervention code [1] 322217 0
Treatment: Surgery
Comparator / control treatment
The control group will have their colonic polyps removed as per standard of care with a snare. No additional treatment will be provided following complete removal of the polyp.
Control group
Active

Outcomes
Primary outcome [1] 329587 0
Rate of adenoma recurrence following polypectomy +/- STSC.

These outcomes will be reviewed at the 6-month mark following a routine post-EMR colonoscopy. Visual inspection and biopsies of the polypectomy site will be obtained.
Timepoint [1] 329587 0
6 months after index colonoscopy (ie. initial polypectomy procedure)
Secondary outcome [1] 403111 0
Rates of adverse events during and following colonoscopy:
- adverse events occurring during the procedure will be documented in the endoscopic report and in the patient medical records
- adverse symptoms in recovery including pain requiring opioids (will be monitored by nursing staff as per standard of care)
- adverse events will also be captured up to 30 days after the procedure with a questionnaire that is supplied to all patients attending for an endoscopic procedure, regardless of whether they are part of a clinical trial or not
- medical records will also be reviewed at the time of data collection to determine whether any unexpected hospital presentations were temporally related to the endoscopic procedure
Timepoint [1] 403111 0
30 days following colonoscopy
Clinical information will be collected on the day of the procedure (ie. any adverse events prior to discharge from hospital) and at the 30 day mark, unless patients contact the research team in the interim

Eligibility
Key inclusion criteria
Patients over 18 years of age who present for an elective colonoscopy will be invited to participate in this study. Subsequently, patients in which an eligible polyp is found and removed will be included in the data collection.

An eligible polyp is an adenomatous appearing polyp 15mm or greater in size with a flat or sessile morphology (Paris 0-Is or 0-IIa) and NICE 2 surface where cold EMR is performed for removal.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with active inflammatory bowel disease
Patients with implanted permanent pacemakers, implanted cardiac defibrillators or spinal cord stimulators

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software will be applied.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Clinical information collected will include patient demographics, procedure details (duration), polyp characteristics (polyp size, location, histology) and rates and types of adverse events. Analyses will be performed comparing the control group to the STSC group to assess whether there were statistically significant differences with regards to different adverse events and adenoma recurrence rates. Subgroup analyses may also be performed to determine whether specific groups of patients were at increased risk of adverse events.
Based on a presumed adenoma recurrence rate of 15% in the control group and a predicted reduction rate to 5% in the STSC group, the sample size required to detect a difference in adenoma recurrence with 80% power and an alpha of 0.05 is 144 patients per group (288 patients total).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
288
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21122 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 35978 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 310173 0
Hospital
Name [1] 310173 0
QEII Jubilee Hospital Gastroenterology Department
Country [1] 310173 0
Australia
Primary sponsor type
Hospital
Name
QEII Jubilee Hospital Gastroenterology Department
Address
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country
Australia
Secondary sponsor category [1] 311936 0
None
Name [1] 311936 0
Address [1] 311936 0
Country [1] 311936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309860 0
Metro South Hospital and Heath Service Human Research Ethics Committee
Ethics committee address [1] 309860 0
Ethics committee country [1] 309860 0
Australia
Date submitted for ethics approval [1] 309860 0
15/11/2021
Approval date [1] 309860 0
23/11/2021
Ethics approval number [1] 309860 0
HREC/2021/QMS/79000

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

Contacts
Principal investigator
Name 115638 0
Dr Nicholas Tutticci
Address 115638 0
QEII Hospital
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country 115638 0
Australia
Phone 115638 0
+61 731824300
Fax 115638 0
Email 115638 0
[email protected]
Contact person for public queries
Name 115639 0
Xuan Banh
Address 115639 0
QEII Hospital
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country 115639 0
Australia
Phone 115639 0
+61 731826111
Fax 115639 0
Email 115639 0
[email protected]
Contact person for scientific queries
Name 115640 0
Xuan Banh
Address 115640 0
QEII Hospital
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country 115640 0
Australia
Phone 115640 0
+61 731826111
Fax 115640 0
Email 115640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be shared including:
Patient demographics - age, gender
Date and details of their colonoscopy and the polyp that was removed, and whether treatment was administered or whether they were in the control group
Outcomes post procedure
Outcomes at follow up endoscopy with regards to the primary outcome (recurrence rate)
When will data be available (start and end dates)?
Data will be available once completely collected (anticipating end 2023)
Available to whom?
This will be available to researchers interested in analysing data in a meta-analysis
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
The principal investigator of this study can be contacted by email


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14126Study protocol    383145-(Uploaded-07-02-2022-10-04-57)-Study-related document.pdf
14127Informed consent form    383145-(Uploaded-15-08-2022-10-35-51)-Study-related document.pdf
14128Ethical approval    383145-(Uploaded-21-12-2021-14-59-30)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.