Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000742279
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
3/05/2018
Date last updated
10/04/2019
Date data sharing statement initially provided
10/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cold Snare Polypectomy for non-pedunculated colonic polyps sized 10-19mm: A prospective observational study.
Scientific title
Cold Snare Polypectomy for non-pedunculated colonic polyps sized 10-19mm: A prospective observational study (CSP study).
Secondary ID [1] 293737 0
None
Universal Trial Number (UTN)
U1111-1207-3689
Trial acronym
CSP study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Colonic adenomas 306105 0
Condition category
Condition code
Oral and Gastrointestinal 305233 305233 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Removal of polyps via colonoscopy is effective at reducing the incidence of colorectal cancer. Cold snare polypectomy (CSP) is a relatively recent development but has rapidly gained international acceptance as an effective and safe polypectomy technique. In this technique, a dedicated snare made up of thin, monofilament wire is used to resect polyps without application of the heat(hence called cold snare polypectomy technique). It is now the standard of care internationally for resection of small polyps (i.e. sized <10mm), and has become the standard of care for resection of intermediate-sized polyps (sized 10-19mm) at leading academic endoscopy centres all around Australia and New Zealand.

While the evidence for the efficacy of cold snare polypectomy for resection of small polyps is established, rigorous data for intermediate sized polyps is still limited. Effectively, this technique has become the standard of care at leading centres for polyps in this size range due to the overwhelming safety benefits, however, there are no prospective nor multicentre studies proving that this method is effective, in terms of completeness of resection of polyps. In our own practices, and in the setting of small, published retrospective studies, we have observed cold snare polypectomy to be very effective for polyps in this intermediate size range as well. However, to convince endoscopists that the safety benefits of cold snare polypectomy are also associated with highly effective complete resection of polyps, a well-designed, prospective, multicentre, observational study is required.


All follow ups of the patients are part of the standard of care.
During the first clinic follow up which is anywhere from 4 weeks to 12 weeks, information related to any delayed complications that have occurred will be documented.

Similarly, first surveillance colonoscopy is also part of the standard of care which can be anywhere from 4 months to three years. Follow up colonoscopy information is collected after patients' first surveillance colonoscopy.
In broader sense maximal possible duration of follow up for any suitable patient is three years from the time of the date of their index colonoscopy. However follow up is very focused at two specific points. First one during initial clinic review post procedure second post first surveillance colonoscopy.
Intervention code [1] 300023 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304435 0
The primary outcome measure is the incomplete resection rate of sessile polyps measuring 10-19mm as determined by the histological examination of polypectomy site biopsies.1`


Incomplete resection is defined as the presence of residual polyp in the biopsies taken from the polyp resection margins or from the central area of the polypectomy defect.

Timepoint [1] 304435 0
Primary endpoint is assessed at the time of the index proedure and further on day 14 post procedure.
Secondary outcome [1] 341923 0
Outcome: To identify residual or recurrent polyp
Assessed by reviewed electronic medical records.
Timepoint [1] 341923 0
First surveillance colonoscopy is performed anytime from 4 months to three years since the index colonoscopy.
All patients who undergo surveillance colonoscopy during the study period will be included in the assessment of this secondary endpoint.
Secondary outcome [2] 342483 0
Intraprocedural bleeding requiring intervention determined using hospital records and procedure reports
Timepoint [2] 342483 0
Immediate post-procedure period.
Secondary outcome [3] 342484 0
Post-procedural unplanned admission for pain or serositis determined by review of medical records.
Timepoint [3] 342484 0
Immediate post-procedure period.
Secondary outcome [4] 342485 0
Exploratory outcome: Polyp details (anatomic location, polyp histology, en bloc vs piecemeal, ease of polyp resection (easy, moderately difficult or difficult)) assessed by review of medical records.
Timepoint [4] 342485 0
Immediate post procedure period
Secondary outcome [5] 342486 0
Complete polypectomy as defined by endoscopist impression of complete polyp resection
Timepoint [5] 342486 0
At the time of index colonoscopy
Secondary outcome [6] 342487 0
Use of submucosal injection (and details of the content of the injection) assessed by review of medical records.
Timepoint [6] 342487 0
At the time of the procedure
Secondary outcome [7] 342488 0
Performance of a CT scan or chest/abdominal x-ray to exclude perforation post procedure assessed by review of medical records.
Timepoint [7] 342488 0
At the time of the index procedure
Secondary outcome [8] 342489 0
Polypectomy duration is assessed using electronic medical records.

Timepoint [8] 342489 0
At the time of the procedure
Secondary outcome [9] 342494 0
Readmission within 14 days post-procedure for a polypectomy related complication. Readmission rate is assessed by reviewing electronic medical records.

Examples of potential adverse events include delayed post-polypectomy bleeding, abdominal pain, perforation
Timepoint [9] 342494 0
Noted during first clinic review within 4-8 weeks since the index procedure
Secondary outcome [10] 342495 0
Unplanned presentation to medical attention, without hospital admission within 14 days post-procedure for a polypectomy related adverse events (e.g presentation to General Practitioner or Emergency Department without warranting a hospital admission) is measured by reviewing electronic medical records.

Timepoint [10] 342495 0
Noted during first clinic review within 4-8 weeks since the index procedure
Secondary outcome [11] 342496 0
Surgery for a polypectomy related complication is assessed by reviewing electronic medical records.

Timepoint [11] 342496 0
Noted during first clinic review within 4-8 weeks since the index procedure
Secondary outcome [12] 342497 0
Clinically significant delayed post-polypectomy bleeding on antiplatelet or anticoagulant therapy is assessed by reviewing electronic medical records.
.
Timepoint [12] 342497 0
Noted during first clinic review within 4-8 weeks since the index procedure
Secondary outcome [13] 342498 0
Assessment of additional hospital costs incurred for the management of polypectomy related adverse events is assessed by reviewing electronic medical records.
Potential additional costs incurred include ED presentation, ward admission per day, ICU admission per day, Blood product transfusion per unit, cost of repeat colonoscopy.
Timepoint [13] 342498 0
Pooled results of all cumulative expenses will be presented around 8 weeks post index procedure.
Secondary outcome [14] 342499 0
Death of any cause is assessed by reviewing electronic medical records.

Timepoint [14] 342499 0
2 weeks from the index procedure

Eligibility
Key inclusion criteria
Any patient undergoing colonoscopy who is older than 18 years of age with sessile polyp measuring 10-19mm that is suitable for polypectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Polyps that are concerning for malignancy
- Pedunculated polyp
- Active inflammatory bowel disease/colitis
- Pregnant
- Aged younger than 18 years
- Presence of bleeding or coagulation disorders
- All polyps resected using hot snare polypectomy (HSP) technique
- A patient where polyps sized 20mm or greater were resected using cold snare during the same procedure

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study is a prospective audit of all new cases of CSP for one year with an additional follow up to review endoscopic findings during the first routine surveillance colonoscopy (SC1). At least five leading endoscopy centres around Australia are expected to contribute to the study. 350 polypectomy cases are expected to be recruited during the study during the first year, another three years of follow up is required to obtain results of the surveillance colonoscopies.

The estimates of recurrence rate in medium-sized polyps with the use of CSP are lacking in the current literature, therefore sample size estimation is not possible. 350 polypectomy cases have been chosen as this is a volume of polypectomies that is likely to be recruited within 1 year thus eliminating the effect of the change in standard of care. Furthermore, this sample will enable fairly small confidence intervals for each of the outcomes and will allow a superiority margin of 5.5% when compared to recurrence rate from the CARE study(17%). If the 350 polyp target is not reached within a year, the study will be extended until this number of polyps is recruited.
The primary analysis will involve detailed descriptives of primary, secondary and exploratory outcomes within CSP cohort. Where possible, outcomes of this study will be compared to the outcomes of already published CARE study (HSP cohort) using binomial probability test for categorical variables and one-sample t-test for continuous variables (polypectomy duration).
Additional analysis will explore which patient‘s, polyp‘s and procedural characteristics are associated with each of the outcomes using univariate analysis (Fisher’s exact and Wilcoxon rank sum test) and multivariate logistic regression.
A p value of < 0.05 will be considered significant. Statistical analyses will be performed with SPSS statistical software (IBM Corp. 2012. IBM SPSS Statistics, Version 21.0. Armonk, NY) and/or Stata 14.2 (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP.) with the help of an independent statistician.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2018
Date of last participant enrolment
Anticipated
14/04/2019
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
350
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 9737 0
Footscray Hospital - Footscray
Recruitment hospital [2] 9738 0
The Alfred - Prahran
Recruitment hospital [3] 9739 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 9740 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [5] 9741 0
St John of God Hospita, Geelong - Geelong
Recruitment hospital [6] 9742 0
Epworth Richmond - Richmond
Recruitment hospital [7] 9743 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 9744 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 9745 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [10] 9746 0
The Wesley Hospital - Auchenflower
Recruitment hospital [11] 9747 0
Westmead Hospital - Westmead
Recruitment hospital [12] 9748 0
Peel Health Campus - Mandurah
Recruitment hospital [13] 9749 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [14] 9750 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [15] 9751 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [16] 13599 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 18516 0
3011 - Footscray
Recruitment postcode(s) [2] 18517 0
3004 - Prahran
Recruitment postcode(s) [3] 18518 0
3050 - Parkville
Recruitment postcode(s) [4] 18519 0
3220 - Geelong
Recruitment postcode(s) [5] 18520 0
3121 - Richmond
Recruitment postcode(s) [6] 18521 0
5042 - Bedford Park
Recruitment postcode(s) [7] 18522 0
5000 - Adelaide
Recruitment postcode(s) [8] 18523 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 18524 0
4066 - Auchenflower
Recruitment postcode(s) [10] 18525 0
2145 - Westmead
Recruitment postcode(s) [11] 18526 0
6210 - Mandurah
Recruitment postcode(s) [12] 18527 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 18528 0
4120 - Greenslopes
Recruitment postcode(s) [14] 18529 0
4029 - Herston
Recruitment postcode(s) [15] 26260 0
3350 - Ballarat Central
Recruitment postcode(s) [16] 26261 0
3350 - Ballarat Central

Funding & Sponsors
Funding source category [1] 298351 0
Hospital
Name [1] 298351 0
Western Health Research Grant
Country [1] 298351 0
Australia
Primary sponsor type
Individual
Name
Dr Dileep Mangira
Address
Western Health,
160 Gordon Street,
Footscray
Victoria 3011
Country
Australia
Secondary sponsor category [1] 297473 0
None
Name [1] 297473 0
Address [1] 297473 0
Country [1] 297473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299346 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 299346 0
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australia.
Ethics committee country [1] 299346 0
Australia
Date submitted for ethics approval [1] 299346 0
30/03/2017
Approval date [1] 299346 0
10/10/2017
Ethics approval number [1] 299346 0
HREC/17/MH/114

Summary
Brief summary
Cold snare polypectomy (CSP) is a relatively recent development but has rapidly gained international acceptance as an effective and safe polypectomy technique. It is now the standard of care internationally for resection of small polyps (i.e. sized <10mm), and has become the standard of care for resection of intermediate-sized polyps (sized 10-19mm) at leading academic endoscopy centres. It has not yet been adopted at most other non-academic endoscopy centres for polyps in this intermediate size range. It is now known that “cold snares” (that don’t use electrocautery) are effective for polyp resection. Cold snares use a thin, stiff, monofilament wire to cut out the polyp, without the need for electrocautery. This is a big advance, as it is the electrocautery that is the main cause of post-polypectomy complications such as bowel perforation, serositis, post-polypectomy syndrome, post-procedure pain and post-polypectomy bleeding. Therefore, polypectomy using cold snare has the potential to significantly reduce the risk of complications following colonoscopy. While the evidence for the efficacy of cold snare polypectomy for resection of small polyps is established, rigorous data for intermediate-sized polyps is still limited. In our own practices, and in the setting of small, published retrospective studies, we have observed cold snare polypectomy to be very effective for intermediate-sized polyps as well. However, to establish robust evidence, a well-designed, prospective, multicentre, observational study is required.
The primary aim of this prospective observational multicentre study is to measure the incomplete resection rate of intermediate-sized sessile polyps as determined by the histological examination of polypectomy site biopsies. The major secondary aims include to measure residual polyp rate during first surveillance colonoscopy, measurement of immediate and delayed complications.
All patients undergoing elective colonoscopy at all participating academic centres will be screened to assess their eligibility into the study based on exclusion and inclusion criteria. During the colonoscopy procedure if a medium sized polyp (10-19 mm) is detected and excised using cold snare polypectomy technique will become the part of the study. Study data Study data from multiple sites will be entered into an encrypted, password protected web-based database.
The study is a prospective audit of all new cases of CSP for one year with an additional follow up to review endoscopic findings during the first routine surveillance colonoscopy. At least fifteen leading endoscopy centres around Australia are expected to contribute to the study. 350 polypectomy cases are expected to be recruited during the study during the first year, another two to three years of follow up is required to obtain results of the surveillance colonoscopies.
Trial website
Trial related presentations / publications
Public notes
Trial has been presented at Western Health Reseach week.
Trial won a research grant of 29,000 AUDs. Funds will be used to set up centralised database for all participating sites to submit data directly in a de-identified manner.
Attachments [1] 2377 2377 0 0
/AnzctrAttachments/374268-Study protocol 13th Dec approved.docx (Protocol)
Attachments [2] 2378 2378 0 0
/AnzctrAttachments/374268-CSP study ethics approval.pdf (Ethics approval)
Attachments [3] 2379 2379 0 0
/AnzctrAttachments/374268-Datasheet 1 for day of the procedure.docx (Other)
Attachments [4] 2382 2382 0 0
/AnzctrAttachments/374268-Datasheet 3 for first surveillance.docx (Other)

Contacts
Principal investigator
Name 80130 0
Dr Dileep Mangira
Address 80130 0
Western Health,
160 Gordon Street,
Footscray, 3011
Victoria
Country 80130 0
Australia
Phone 80130 0
+61383456666
Fax 80130 0
Email 80130 0
[email protected]
Contact person for public queries
Name 80131 0
Dr Dileep Mangira
Address 80131 0
Western Health,
160 Gordon Street,
Footscray, 3011
Victoria
Country 80131 0
Australia
Phone 80131 0
+61383456666
Fax 80131 0
Email 80131 0
[email protected]
Contact person for scientific queries
Name 80132 0
Dr Dileep Mangira
Address 80132 0
Western Health,
160 Gordon Street,
Footscray, 3011
Victoria
Country 80132 0
Australia
Phone 80132 0
+61383456666
Fax 80132 0
Email 80132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Cumulative results are meaningful rather than individual outcomes.


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23594Study protocolNil [email protected] Nil 374268-(Uploaded-11-03-2021-22-28-45)-Study-related document.docx
23595Study protocolNA [email protected] NA 374268-(Uploaded-18-03-2020-20-42-49)-Study-related document.pdf
23596Statistical analysis planAN [email protected] NA 374268-(Uploaded-18-03-2020-20-45-53)-Study-related document.pdf
23597Informed consent formNA [email protected] NA 374268-(Uploaded-18-03-2020-20-47-08)-Study-related document.pdf
23598Clinical study reportNA [email protected] NA 374268-(Uploaded-18-03-2020-20-48-04)-Study-related document.pdf
23599Ethical approval    374268-(Uploaded-18-03-2020-20-48-49)-Study-related document.pdf
23600Analytic code    374268-(Uploaded-18-03-2020-20-49-22)-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.