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Trial registered on ANZCTR


Trial ID
ACTRN12613001190796
Ethics application status
Approved
Date submitted
2/10/2013
Date registered
30/10/2013
Date last updated
30/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of different endoscopic modalities for the detection of dysplasia and early cancer in patients with Barrett's Oesophagus undergoing surveillance endoscopy.
Scientific title
The accuracy, sensitivity, specificity, positive predictive value and negative predictive value of Narrow Band Imaging versus White Light Endoscopy (standard of care) in the detection of dysplasia and early cancer in patients with Barrett's Oesophagus undergoing surveillance endoscopy.
Secondary ID [1] 283317 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett's Oesophagus 290205 0
Condition category
Condition code
Oral and Gastrointestinal 290598 290598 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 290702 290702 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Narrow Band Imaging (NBI) with dual focus magnification are endoscopic imaging technologies which can be utilized with a switch of a button on the endoscope. Images can then be obtained which may enable better visualization of the Barrett’s segment. These are non invasive technologies where the light at the end of the endoscope changes to a more ‘narrow wave length light’ which could improve visualization of vasculature which can be more pronounced in early neoplasia. Patient’s will either receive the white light endoscopy (WLE) examination followed by examination with NBI or examination with the NBI followed by WLE. Any suspicious areas detected by both modalities will be documented (location and distance from incisors) and subsequently further assessed with Narrow Band Imaging with Dual Focus (NBI-DF) where ‘optical biopsies’/ interpretation of the histology will be made in real time. Targeted biopsies will then be taken. This will then be followed by random 4 quadrant biopsies on WLE. The time taken to perform the examination on NBI and NBI-DF as well as time taken to perform the examination on WLE will be documented. All images with all modalities will be recorded and stored in high definition files. All biopsies corresponding to the imaged areas on all modalities will be documented, labeled separately and sent for blinded histopathological examination.
The addition of Narrow Band Imaging and dual focus magnification (to white light endoscopy) may increase the procedure time by up to 5 minutes in addition to the standard of care (see below comparetor/control treatment).
The number of times that the test will be undertaken by the patient, will be only once at the baseline procedure.
Intervention code [1] 288036 0
Early detection / Screening
Intervention code [2] 288126 0
Diagnosis / Prognosis
Comparator / control treatment
White light endoscopy and random biopsies are the standard of care for patients who undergo surveillance endoscopy. The duration of the procedure is no longer than what is practiced presently and can vary from patient to patient. The procedure generally takes about 5-10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 290608 0
The Sensitivity, Specificity, Positive and Negative Predictive Values will be compared to the final histopathology assessment using both white light and then NBI or vice versa (based on randomization).

Timepoint [1] 290608 0
4 years. All participants will be enrolled over a 4 year time frame and the performance of NBI will be directly compared to final histopathology.
Secondary outcome [1] 304901 0
Any abnormal area found on the above 2 modalities will be interrogated with NBI-DF and compared with final histology.
Timepoint [1] 304901 0
4 years. All participants will be enrolled over a 4 year time frame and the performance of NBI-DF will be directly compared to final histopathology.

Eligibility
Key inclusion criteria
1. Patients aged 18-85 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 0.5cm
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
85 Years
Gender
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

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)
All suitable patients with known Barrett's Oesophagus (BE) presenting for surveillance or referred for further workup of dysplasia and early cancer will be initially seen in the outpatients clinic, informed of the study by the Endoscopists performing the procedure and a research nurse/assistant and be provided with a patient information sheet and consent form. Demographics such as age, gender, indication, duration of BE diagnosis will be collected once consent is obtained.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)will be utilised in the study.
Randomization (1:1) with opaque sealed envelopes will then be performed by the research nurse/assistant who will be present throughout the procedure documenting the relevant data.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants receive all the interventions in different sequences during the study. They act as their own control
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The calculated prevalence of dysplasia with a cohort of patients undergoing surveillance endoscopy and referred for further assessment of dysplasia and early cancer is 17%. For a power of 80% with a 0.05% significance and an incremental gain of 30% with NBI and NBI-DF (note: WLE: presumed 60% of dysplasia detected, NBI+NBI-DF: 90%); a total of 182 patients will need to be recruited (Controlled Clin. Trials, 1997; 18:274).
Analyses of the data collected will then be conducted using the SPSS and STATA software.





Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1554 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 7391 0
5112 - Elizabeth

Funding & Sponsors
Funding source category [1] 288050 0
Charities/Societies/Foundations
Name [1] 288050 0
Cancer Australia
Address [1] 288050 0
Cancer Australia
PO Box 1201
Dickson ACT 2602

Country [1] 288050 0
Australia
Funding source category [2] 288123 0
Charities/Societies/Foundations
Name [2] 288123 0
Cure Cancer Australia Foundation
Address [2] 288123 0
Cure Cancer Australia Foundation
Level 6, Young St.,
Sydney
NSW 2000
Country [2] 288123 0
Australia
Primary sponsor type
Individual
Name
A/Prof.Rajvinder Singh
Address
Lyell McEwin Hospital,
Haydown Rd,
Elizabeth Vale,
SA 5112.
Country
Australia
Secondary sponsor category [1] 286864 0
Charities/Societies/Foundations
Name [1] 286864 0
Cure Cancer Australia Foundation
Address [1] 286864 0
Cure Cancer Australia Foundation
Level 6, Young St.,
Sydney
NSW 2000
Country [1] 286864 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289984 0
Ethics of Human Research Committee
Ethics committee address [1] 289984 0
The Queen Elizabeth Hospital
28, Woodville Road
Woodville South SA 5011
Ethics committee country [1] 289984 0
Australia
Date submitted for ethics approval [1] 289984 0
Approval date [1] 289984 0
25/09/2008
Ethics approval number [1] 289984 0
2008128

Summary
Brief summary
This project will examine the utility of a novel endoscopic imaging device (Narrow Band Imaging – NBI) and compare this technology against the present standard of care in patients with a chronic premalignant condition known as Barrett's Oesophagus.
Who is it for? You may be eligible to join this study if you are aged between 18-85 years and are scheduled to undergo surveillance endoscopy for Barrett’s Oesophagus (BE), or have been referred for further assessment of dysplasia/early cancer in BE.
Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard care, which consists of white light endoscopy (WLE) and random biopsies followed by examination with NBI and NBI and dual focus magnification (NBI-DF). Participants in the other group, will receive an examination with NBI and with NBI-DF in addition to standard care. NBI and NBI-DF are endoscopic imaging technologies which can be utilized with a switch of a button on the endoscope. Images can then be obtained which may enable better visualization of the Barrett’s segment. These are non invasive technologies where the light at the end of the endoscope changes to a more ‘narrow wave length light’ which could improve visualization of vasculature which can be more pronounced in early neoplasia. Targeted and random biopsies will then be taken. Endoscopy results will be compared to histology to determine whether NBI and NBI-DF can improve the detection of precursors of cancer or early cancer which may enable earlier and less invasive interventions for these patients.
All patients will receive the same treatments,but in a random order.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43330 0
A/Prof Rajvinder Singh
Address 43330 0
Endoscopy Unit,
Lyell McEwin Hospital, Haydown Rd,
Elizabeth Vale,
5112 SA
Country 43330 0
Australia
Phone 43330 0
+61 8 81829909
Fax 43330 0
+61 8 81829837
Email 43330 0
rajvinder.singh@health.sa.gov.au
Contact person for public queries
Name 43331 0
A/Prof Rajvinder Singh
Address 43331 0
Endoscopy Unit,
Lyell McEwin Hospital, Haydown Rd,
Elizabeth Vale,
5112 SA
Country 43331 0
Australia
Phone 43331 0
+61 8 81829909
Fax 43331 0
+61 8 81829837
Email 43331 0
rajvinder.singh@health.sa.gov.au
Contact person for scientific queries
Name 43332 0
A/Prof Rajvinder Singh
Address 43332 0
Endoscopy Unit,
Lyell McEwin Hospital, Haydown Rd,
Elizabeth Vale,
5112 SA
Country 43332 0
Australia
Phone 43332 0
+61 8 81829909
Fax 43332 0
+61 8 81829837
Email 43332 0
rajvinder.singh@health.sa.gov.au