None listed
Conditions
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.
Interventions
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 recei
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.
Sponsors
A/Prof.Rajvinder Singh
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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)
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
Outcome results
None listed