Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000657123p
Ethics application status
Submitted, not yet approved
Date submitted
20/04/2019
Date registered
1/05/2019
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using image enhancement in colonoscopy to increase detection of colonic polyps
Scientific title
Utilising image enhancement with Blue light Imaging (BLI) and Linked Colour Imaging (LCI) to increase detection of colonic neoplasia; a prospective randomised controlled trial.
Secondary ID [1] 298023 0
Nil known
Universal Trial Number (UTN)
U1111-1232-0520
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic adenomas 312476 0
Condition category
Condition code
Oral and Gastrointestinal 311022 311022 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 311117 311117 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, we aim to compare the adenoma detection rate with Linked Colour Imaging (LCI) in patients undergoing elective colonoscopy at Gold Coast University Hospital. Our overall objective is to demonstrate whether LCI increases the adenoma detection rate compared with high-definition white light (WL; current standard of care).

All procedures will be performed by experienced colonoscopists or fellows already familiar with the Fujifilm colonoscopy system which has LCI in-built (ELUXEO, FUJIFILM Co., Tokyo, Japan) and accessible with the simple push of a button. The endoscopes are currently used for routine practice and procedures in our endoscopy unit (including both high-definition white light and LCI).

Prior to enrolment of patients, study endoscopists’ baseline adenoma detection rates will be recorded based on data from 100 prior consecutive colonoscopies. Endoscopists will be classified as baseline expert or non-expert adenoma detectors and adenoma detection assessed both according to group and on an individual basis.

Each participant will undergo a single colonoscopy. Participants will be randomised once to examination either under LCI or high-definition WL, with both insertion and withdrawal performed using the same modality. All patients will be sedated by anaesthetist-led propofol sedation as is our current practice.

Polyps will be evaluated under Blue Light Imaging (BLI) for characteristic features. They will be removed as they are identified (via standard polypectomy techniques) and submitted for pathological examination. Pathology will be utilised to confirm the presence of polyp tissue.
Intervention code [1] 314254 0
Treatment: Other
Comparator / control treatment
Patients undergoing elective colonoscopy using high-definition white light.
Control group
Active

Outcomes
Primary outcome [1] 319818 0
The adenoma detection rates for high definition white light and LCI
Timepoint [1] 319818 0
At time of colonoscopy
Secondary outcome [1] 369598 0
Differences in adenoma detection rates for high definition white light and LCI between expert and non-expert endoscopists
Timepoint [1] 369598 0
Measured at time of colonoscopy
Secondary outcome [2] 369599 0
The adenoma detection rates for high definition white light and LCI stratified by polyp type, size and location
Timepoint [2] 369599 0
Measured at time of colonoscopy

Eligibility
Key inclusion criteria
Patients undergoing elective colonoscopy at the Gold Coast University Hospital will be eligible for recruitment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years of age
Complex cases for advanced therapeutic colonoscopy (endoscopic mucosal resection, endoscopic submucosal dissection, colonic stenting, colonic dilatation, colonic strictures)
Known polyposis syndromes.
Previous surgical resection of the colon or rectum
Inadequate bowel preparation
Active inflammatory bowel disease

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 will be concealed in sealed opaque envelopes and only be revealed at commencement of colonoscopy, after consent for participation has been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed in blocks of 4 by utilising computerised sequence generation.
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
Efficacy
Statistical methods / analysis
The current recommended minimum benchmark ADR in an average-risk screening population is 25%, although suggested that this may need to be increased to as much as 55% for high-risk patients.

If we assume a baseline ADR of 25% in high-definition white light, and an ADR of 45% with LCI: for the study to have 80% power to detect this 20% increase in ADR, by using a chi-square test with 5% significance level, the study will need 172 patients.

Thus recruitment of 200 patients (100 per arm) will ensure that the study fulfils the above power criteria.

Overall adenoma detection rates (ADRs) will be compared between colonoscopies performed under high-definition white light and LCI using 2-sample t-tests. Comparisons will also be performed by group classification as expert or non-expert detectors, to assess for any difference in ADRs between high-definition white light and LCI within each of these groups. ADRs will also be compared by polyp type, location and size, between the two primary groups of high-definition white light and LCI.

Differences in age, withdrawal time and propofol dose will be assessed using 2-sample t-tests. Differences in sex and indication will be assessed using chi-square tests. Differences in quality of bowel preparation will be assessed using a Mantel-Haenszel test for ordered categories.

Endoscopists will be compared for differences in insertion time, inspection time, and total time by using analysis of variance models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2019
Actual
Date of last participant enrolment
Anticipated
19/05/2020
Actual
Date of last data collection
Anticipated
19/06/2020
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13645 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 26317 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 302551 0
Hospital
Name [1] 302551 0
Gold Coast University Hospital
Country [1] 302551 0
Australia
Primary sponsor type
Individual
Name
Sneha John
Address
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country
Australia
Secondary sponsor category [1] 302458 0
Individual
Name [1] 302458 0
Emily JY Lim
Address [1] 302458 0
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country [1] 302458 0
Australia
Secondary sponsor category [2] 302459 0
Individual
Name [2] 302459 0
Aiden Lyon
Address [2] 302459 0
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country [2] 302459 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303195 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 303195 0
Office for Research Governance and Development
Level 2, Pathology and Education Building
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 303195 0
Australia
Date submitted for ethics approval [1] 303195 0
14/03/2019
Approval date [1] 303195 0
Ethics approval number [1] 303195 0
HREC/2019/QGC/52019

Summary
Brief summary
Our overall objective is to demonstrate whether LCI increases the detection rate compared with high-definition white light (current standard of care).

The purpose of this study is to compare the rates of polyp detection with Linked Colour Imaging (LCI) and high-definition white light in patients undergoing elective colonoscopy.

Who is it for?
You may be eligible for this study if you are aged over 18 and are undergoing elective colonoscopy at the Gold Coast University Hospital.

Study details
All participants in this study will undergo a single colonoscopy as planned. The type of light used will be randomised by chance. We will record where polyps were found and their size. Any cancerous or pre-cancerous appearing lesions detected will be treated as per standard procedure. Resected polyps will be pathology tested as part of your routine care. No tissue samples will be obtained or stored purely for research purposes alone. The results of your tissue analysis will be de-identified and used only to confirm that lesions seen during your colonoscopy were really polyps.

It is hoped this research will demonstrate whether LCI increases the detection rate compared with the current standard of high-definition white light.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92814 0
Dr Sneha John
Address 92814 0
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country 92814 0
Australia
Phone 92814 0
+61 7 5687 0000
Fax 92814 0
Email 92814 0
Sneha.John@health.qld.gov.au
Contact person for public queries
Name 92815 0
Dr Emily Lim
Address 92815 0
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country 92815 0
Australia
Phone 92815 0
+61 7 5687 0000
Fax 92815 0
Email 92815 0
Emily.Lim@health.qld.gov.au
Contact person for scientific queries
Name 92816 0
Dr Emily Lim
Address 92816 0
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country 92816 0
Australia
Phone 92816 0
+61 7 5687 0000
Fax 92816 0
Email 92816 0
Emily.Lim@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant privacy including both endoscopists and patients


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.