Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000708853
Ethics application status
Approved
Date submitted
22/04/2021
Date registered
8/06/2021
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized comparison between White Light Endoscopy (WLE) and Texture Color Enhancement Imaging (TXI) in detection of colon polyps at colonoscopy
Scientific title
A randomized comparison between White Light Endoscopy (WLE) and Texture Color Enhancement Imaging (TXI) in the diagnosis of colonic adenomas in patients undergoing colonoscopy
Secondary ID [1] 304029 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic adenomas 321660 0
Condition category
Condition code
Oral and Gastrointestinal 319409 319409 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Texture and Colour Enhancement Imaging (TXI) at Colonoscopy

This study will involve the use of TXI, a new form of imaging processing on the EVIS X1 Olympus endoscopy system.

Participants who have been referred for colonoscopy are randomized to receive a colonoscopy examination using either a WLE or TXI using the same processor.

In each study Participant the colonoscope will be inserted to the caecum, then based on randomization, colonic mucosa will be examined using either WLE or TXI on scope withdrawal. An endoscopy assistant will time the procedure starting from scope withdrawal using a stopwatch. The watch will be stopped at the time of polyp removal/biopsies. A minimum of 6 minutes withdrawal time is stipulated.

Recorded parameters include number and location of adenomas, their size, morphology and pit pattern according to the Kudo’s and NICE classification. Switching from WLE to TXI and vice versa is permitted at the discretion of endoscopist after detection of an adenoma. Endoscopists may elect to remove these adenomas using WLE.

Adenoma size is measured by a comparison to known diameter of open forceps and grouped into size categories. The decision to perform biopsies or hot/cold snare will be left up to the discretion of the endoscopist. Each polyp will be retrieved separately for pathologic examination.

The procedures will all be performed by experienced gastroenterologists in a tertiary teaching hospital.
Intervention code [1] 320360 0
Early detection / Screening
Intervention code [2] 320361 0
Treatment: Other
Comparator / control treatment
The control group will receive a routine colonoscopic examination using white light endoscopy (WLE).
Control group
Active

Outcomes
Primary outcome [1] 327279 0
Adenoma detection rate of TXI compared to WLE
Timepoint [1] 327279 0
During colonoscopy
Secondary outcome [1] 394454 0
Median number of adenomas detected per colonoscopy using TXI compared to WLE
Timepoint [1] 394454 0
During colonoscopy
Secondary outcome [2] 394455 0
Withdrawal time measured using a stopwatch (which will be paused for polyp characterisation and polypectomy)
Timepoint [2] 394455 0
During colonoscopy

Eligibility
Key inclusion criteria
All patients referred for colonoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Inability or refusal to give informed consent
2. Patients with coagulation disorders
3. Patients with significant comorbidity, which includes severe heart failure, chronic renal disease, severe chronic obstructive airways disease.
4. Patients who are pregnant
5. Personal history of inflammatory bowel disease
6. Family history of Familial Adenomatous Polyposis or familial non-polyposis syndrome

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by a random number generator, with odd numbers randomised to WLE and even to TXI.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were based on a current overall adenoma detection rate of 30% using WLE (with the minimum GESA certification standard being 25%) and an estimated 50% increase in adenoma detection with TXI. For a power of 80% and alpha of 0.05, the required sample size would be 324.

Comparisons will be made using chi-squared tests for categorical variables and unpaired t-tests for numerical variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2021
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
1/08/2022
Actual
Sample size
Target
324
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19177 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 33749 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 308412 0
University
Name [1] 308412 0
University of Adelaide
Country [1] 308412 0
Australia
Primary sponsor type
Individual
Name
Edward Young
Address
Lyell McEwin Hospital, Haydown Rd, Elizabeth Vale 5112
Country
Australia
Secondary sponsor category [1] 309245 0
None
Name [1] 309245 0
None
Address [1] 309245 0
None
Country [1] 309245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308374 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 308374 0
Royal Adelaide Hospital, Port Road, Adelaide SA 5000
Ethics committee country [1] 308374 0
Australia
Date submitted for ethics approval [1] 308374 0
24/09/2020
Approval date [1] 308374 0
16/11/2020
Ethics approval number [1] 308374 0
13900

Summary
Brief summary
This study involves using a new imaging processor (TXI) while performing a colonoscopy looking for colon polyps (pre-cancerous growths). The aim is to assess whether TXI is able to detect more polyps than usual colonoscopic imaging. In order to determine if there is any significant difference, we will randomise patients either to a routine colonoscopy or to colonoscopy using TXI. We will then document the number of polyps found with each imaging type if they are confirmed as pre-cancerous when examined by a pathologist under the microscopy, then compare the two methods statistically.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110486 0
Dr Edward Young
Address 110486 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, SA
5112
Country 110486 0
Australia
Phone 110486 0
+61 8 81820616
Fax 110486 0
Email 110486 0
[email protected]
Contact person for public queries
Name 110487 0
Dr Edward Young
Address 110487 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, SA
5112
Country 110487 0
Australia
Phone 110487 0
+61 8 81820616
Fax 110487 0
Email 110487 0
[email protected]
Contact person for scientific queries
Name 110488 0
Dr Edward Young
Address 110488 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, SA
5112
Country 110488 0
Australia
Phone 110488 0
+61 8 81820616
Fax 110488 0
Email 110488 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?
A deidentified database (including number and histology of adenomas found at each individual colonoscopy) can be made available on reasonable request to the principal investigator.
When will data be available (start and end dates)?
Data will be available for 5 years from the time of publication.
Available to whom?
Data will be available on reasonable request to the principal investigator on a case-by-case basis at the discretion of the principal investigator.
Available for what types of analyses?
Data will be available for any type of analysis provided the applicants describe a methodologically sound proposal.
How or where can data be obtained?
Data will be accessible subject to approval by the principal investigator, provided via email. To request access to data please email the principal investigator ([email protected])


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
SourceTitleYear of PublicationDOI
Dimensions AITexture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial2023https://doi.org/10.1053/j.gastro.2023.10.008
N.B. These documents automatically identified may not have been verified by the study sponsor.