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Trial registered on ANZCTR


Registration number
ACTRN12621000893808
Ethics application status
Approved
Date submitted
27/04/2021
Date registered
8/07/2021
Date last updated
8/07/2021
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized comparison of Texture Colour Enhancement Imaging (TXI) and Dual Focus magnification (NBI- DF) compared to standard White Light Endoscopy for detection of pre-cancerous changes in adults with Barrett’s Oesophagus
Scientific title
A randomised trial comparing Texture and Colour Enhancement Imaging (TXI) with Dual Focus Magnification Narrow Band Imaging (NBI-DF) versus standard White Light Endoscopy for the detection of dysplasia in adults with Barrett's Oesophagus
Secondary ID [1] 304068 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett's Oesophagus 321717 0
Oesophageal dysplasia 322116 0
Early stage oesophageal cancer 322117 0
Condition category
Condition code
Oral and Gastrointestinal 319458 319458 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 319824 319824 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will involve the use of the Olympus EVIS X1 endoscopy system. For each patient, the oesophagus will be examined using three endoscopic imaging techniques; TXI; white-light endoscopy (WLE); and narrow-band imaging (NBI). Biopsies will be taken from any suspicious areas noted on each form of imaging, as well as random four-quadrant biopsies. The endoscopies will be performed by an expert interventional endoscopist with more than 10 years of endoscopy experience. Each patient will have one endoscopy as part of this study, which will be undertaken at a large tertiary teaching hospital.

There will be no differences encountered by participants related to the use of the differing imaging modalities as all patients will receive all modalities. There may be a marginally longer duration of endoscopy to a maximum of 2-3 minutes (in addition to the usual 10-15 minutes for endoscopy + biopsy) in order to carefully examine the oesophagus using the additional forms of imaging.

All endoscopies will be performed by the study investigators and photographs will be included in the endoscopy reports to ensure adherence to the intervention. In cases where no suspicious areas are detected on imaging, biopsies will be taking in all four quadrants at 2cm intervals throughout the extent of the Barrett's segment as per the Seattle Protocol.

The intervention group will have an endoscopic examination of their Barrett's Oesophagus using TXI, followed by WLE and NBI.
Intervention code [1] 320395 0
Diagnosis / Prognosis
Comparator / control treatment
This will be a parallel study, where each group will receive all forms of imaging. The control group will have endoscopic examination using WLE and NBI, followed by TXI.
Control group
Active

Outcomes
Primary outcome [1] 327337 0
Detection of high-grade dysplasia within Barrett's Oesophagus using Texture and Colour Enhancement Imaging compared to White Light Endoscopy with Narrow-Band Imaging. The sensitivity and specificity will be calculated for both the intervention and control groups compared to histologically confirmed dysplasia on directed or random quadratic biopsies as the gold-standard.
Timepoint [1] 327337 0
During endoscopy
Primary outcome [2] 327689 0
Detection of adenocarcinoma within Barrett's Oesophagus using Texture and Colour Enhancement Imaging compared to White Light Endoscopy with Narrow-Band Imaging. The sensitivity and specificity will be calculated for both the intervention and control groups compared to histologically confirmed dysplasia on directed or random quadratic biopsies as the gold-standard.
Timepoint [2] 327689 0
During endoscopy
Secondary outcome [1] 394640 0
Detection of low-grade dysplasia in Barrett's Oesophagus using Texture and Colour Enhancement Imaging versus White Light Endoscopy with Narrow-Band Imaging. The sensitivity and specificity will be calculated for both the intervention and control groups compared to histologically confirmed dysplasia on directed or random quadratic biopsies as the gold-standard.
Timepoint [1] 394640 0
During endoscopy

Eligibility
Key inclusion criteria
1. Patients aged 18-80 years undergoing surveillance endoscopy for Barrett's Oesophagus (BE) or whom are referred for further assessment of dysplasia/early cancer in BE.

2. Patients with BE length of at least 1cm.

These patients should also be on acid suppressive therapy (Proton Pump Inhibitor at a standard dose for minimum of 4 weeks to prevent inflammation from disrupting interpretation of BE tissue).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability or refusal to give informed consent.
2. Patients with coagulation disorders.
3. Patients with significant co morbidity, which includes severe heart failure, chronic renal disease, chronic obstructive airways disease.
4. Patients who are pregnant.
5. Patients taking anti-coagulation medication.


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 concealment through sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
For a power of 95% with a 0.05% significance and an incremental gain of 25% with TXI ,with WLE: presumed 70% of dysplasia detected, TXI: 95%(16); a total of 114 patients (57 in each arm) will need to be recruited

Analyses of the data collected will then be conducted using the SPSS and STATA software. Calculation of sensitivity, specificity, NPV, PPV and area under receiver operating characteristic will be used to evaluate the primary outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/07/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19213 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 33785 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 308452 0
University
Name [1] 308452 0
University of Adelaide
Country [1] 308452 0
Australia
Primary sponsor type
Individual
Name
Edward Young
Address
Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
Country
Australia
Secondary sponsor category [1] 309288 0
None
Name [1] 309288 0
None
Address [1] 309288 0
None
Country [1] 309288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308406 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 308406 0
Royal Adelaide Hospital
Port Road, Adelaide SA 5000
Ethics committee country [1] 308406 0
Australia
Date submitted for ethics approval [1] 308406 0
29/09/2020
Approval date [1] 308406 0
01/04/2021
Ethics approval number [1] 308406 0
14671

Summary
Brief summary
This study aims to compare a new form of image processing for endoscopy, called Texture and Colour Enhancement Imaging (TXI), with the existing image processing, white light endoscopy (WLE) and Narrow-Band Imaging (NBI) to determine if TXI is better able to detect early cancerous changes in the oesophagus of patients with Barrett's Oesophagus.

Who is it for?
You may be eligible for this study if you are between 18 and 80 years of age and you are undergoing a scheduled endoscopy for Barrett's oesophagus monitoring or you have been referred for further assessment of dysplasia/early cancer because of long term Barrett's oesophagus.

Study details
All participants who choose to enrol in this study will be randomly assigned by chance (similar to flipping a coin) to undergo either TXI followed by WLE and NBI imaging during their endoscopy, or to undergo WLE and NBI followed by TXI during their endoscopy. All participants will undergo both imaging processes, only the order will be randomly assigned. During the endoscopy, tissue biopsies will also be taken to check for cancerous or pre-cancerous cells within the oesophageal tissue. The endoscopy procedure is expected to take up to 15 minutes.

It is hoped this research will determine whether the new TXI image process is able to detect more pre-cancerous cells than previous forms of endoscopic imaging. This new form of imaging may then be used to improve health outcomes of future patients with Barrett's oesophagus, by detecting potential cancers earlier so that treatment can be most effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110606 0
Dr Edward Young
Address 110606 0
Lyell McEwin Hospital, Haydown Rd, Elizabeth Vale, SA 5112
Country 110606 0
Australia
Phone 110606 0
+61 8 81820616
Fax 110606 0
Email 110606 0
[email protected]
Contact person for public queries
Name 110607 0
Edward Young
Address 110607 0
Lyell McEwin Hospital, Haydown Rd, Elizabeth Vale, SA 5112
Country 110607 0
Australia
Phone 110607 0
+61 8 81820616
Fax 110607 0
Email 110607 0
[email protected]
Contact person for scientific queries
Name 110608 0
Edward Young
Address 110608 0
Lyell McEwin Hospital, Haydown Rd, Elizabeth Vale, SA 5112
Country 110608 0
Australia
Phone 110608 0
+61 8 81820616
Fax 110608 0
Email 110608 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 will be available on reasonable request to the principal investigator, including the location and appearance of suspicious areas on each form of imaging, as well as any dysplasia detected on biopsy.
When will data be available (start and end dates)?
Data will be available for 5 years following publication.
Available to whom?
Data will be made available 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 form of statistical analysis provided the applicants describe a methodologically sound proposal.
How or where can data be obtained?
Data will be made available at the discretion of the principal investigator by private email to [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
No additional documents have been identified.