ANZCTR - Registration

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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]

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

Condition category

Condition code

Oral and Gastrointestinal

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Primary endpoint is assessed at the time of the index proedure and further on day 14 post procedure.

Secondary outcome [1]

Outcome: To identify residual or recurrent polyp
Assessed by reviewed electronic medical records.

Timepoint [1]

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]

Intraprocedural bleeding requiring intervention determined using hospital records and procedure reports

Timepoint [2]

Immediate post-procedure period.

Secondary outcome [3]

Post-procedural unplanned admission for pain or serositis determined by review of medical records.

Timepoint [3]

Immediate post-procedure period.

Secondary outcome [4]

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]

Immediate post procedure period

Secondary outcome [5]

Complete polypectomy as defined by endoscopist impression of complete polyp resection

Timepoint [5]

At the time of index colonoscopy

Secondary outcome [6]

Use of submucosal injection (and details of the content of the injection) assessed by review of medical records.

Timepoint [6]

At the time of the procedure

Secondary outcome [7]

Performance of a CT scan or chest/abdominal x-ray to exclude perforation post procedure assessed by review of medical records.

Timepoint [7]

At the time of the index procedure

Secondary outcome [8]

Polypectomy duration is assessed using electronic medical records.

Timepoint [8]

At the time of the procedure

Secondary outcome [9]

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]

Noted during first clinic review within 4-8 weeks since the index procedure

Secondary outcome [10]

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]

Noted during first clinic review within 4-8 weeks since the index procedure

Secondary outcome [11]

Surgery for a polypectomy related complication is assessed by reviewing electronic medical records.

Timepoint [11]

Noted during first clinic review within 4-8 weeks since the index procedure

Secondary outcome [12]

Clinically significant delayed post-polypectomy bleeding on antiplatelet or anticoagulant therapy is assessed by reviewing electronic medical records.
.

Timepoint [12]

Noted during first clinic review within 4-8 weeks since the index procedure

Secondary outcome [13]

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]

Pooled results of all cumulative expenses will be presented around 8 weeks post index procedure.

Secondary outcome [14]

Death of any cause is assessed by reviewing electronic medical records.

Timepoint [14]

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?

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]

Footscray Hospital - Footscray

Recruitment hospital [2]

The Alfred - Prahran

Recruitment hospital [3]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [4]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [5]

St John of God Hospita, Geelong - Geelong

Recruitment hospital [6]

Epworth Richmond - Richmond

Recruitment hospital [7]

Flinders Medical Centre - Bedford Park

Recruitment hospital [8]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [9]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [10]

The Wesley Hospital - Auchenflower

Recruitment hospital [11]

Westmead Hospital - Westmead

Recruitment hospital [12]

Peel Health Campus - Mandurah

Recruitment hospital [13]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [14]

Greenslopes Private Hospital - Greenslopes

Recruitment hospital [15]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [16]

Ballarat Health Services (Base Hospital) - Ballarat Central

Recruitment postcode(s) [1]

3011 - Footscray

Recruitment postcode(s) [2]

3004 - Prahran

Recruitment postcode(s) [3]

3050 - Parkville

Recruitment postcode(s) [4]

3220 - Geelong

Recruitment postcode(s) [5]

3121 - Richmond

Recruitment postcode(s) [6]

5042 - Bedford Park

Recruitment postcode(s) [7]

5000 - Adelaide

Recruitment postcode(s) [8]

5112 - Elizabeth Vale

Recruitment postcode(s) [9]

4066 - Auchenflower

Recruitment postcode(s) [10]

2145 - Westmead

Recruitment postcode(s) [11]

6210 - Mandurah

Recruitment postcode(s) [12]

4102 - Woolloongabba

Recruitment postcode(s) [13]

4120 - Greenslopes

Recruitment postcode(s) [14]

4029 - Herston

Recruitment postcode(s) [15]

3350 - Ballarat Central

Recruitment postcode(s) [16]

3350 - Ballarat Central

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Western Health Research Grant

Address [1]

Western Health,
160 Gordon Street,
Footscray,
Victoria 3011

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Dileep Mangira

Address

Western Health,
160 Gordon Street,
Footscray
Victoria 3011

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE

Ethics committee address [1]

The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australia.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/03/2017

Approval date [1]

10/10/2017

Ethics approval number [1]

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]

/AnzctrAttachments/374268-Study protocol 13th Dec approved.docx (Protocol)

Attachments [2]

/AnzctrAttachments/374268-CSP study ethics approval.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/374268-Datasheet 1 for day of the procedure.docx (Other)

Attachments [4]

/AnzctrAttachments/374268-Datasheet 3 for first surveillance.docx (Other)

Contacts

Principal investigator

Name

Dr Dileep Mangira

Address

Western Health,
160 Gordon Street,
Footscray, 3011
Victoria

Country

Australia

Phone

+61383456666

Fax

dileepmangira@gmail.com

Contact person for public queries

Name

Dileep Mangira

Address

Western Health,
160 Gordon Street,
Footscray, 3011
Victoria

Country

Australia

Phone

+61383456666

Fax

dileepmangira@gmail.com

Contact person for scientific queries

Name

Dileep Mangira

Address

Western Health,
160 Gordon Street,
Footscray, 3011
Victoria

Country

Australia

Phone

+61383456666

Fax

dileepmangira@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Cumulative results are meaningful rather than individual outcomes.

What supporting documents are/will be available?

No Supporting Document Provided

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.

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