Plain English Summary
Background and study aims
Esophageal cancer (adenocarcinoma; EAC) is cancer that starts in the esophagus - the food pipe that runs between the throat and the stomach. EAC is amongst the deadliest cancers, with 5-year survival rates of less than 15%. The incidence of esophageal cancer has risen rapidly over the last decades. Patients with a condition called Barrett’s Esophagus (BE) are at increased risk of developing EAC. In BE the normal lining of the esophagus changes to tissue that resembles the lining of the intestine. BE is caused by gastrointestinal acid reflux (where stomach acid travels up towards the throat). EAC develops through a stepwise process from BE to low-grade and high-grade dysplasia, and eventually to EAC. Therefore, the standard of care for Barrett’s patients consists of regular endoscopies with white-light endoscopy (WLE) and biopsies (tissues samples) to detect EAC at an early stage. When detected at an early stage, patients with EAC can be treated endoscopically with an excellent prognosis. However, EAC in BE patients is difficult to distinguish with WLE alone. Blue Light Imaging (BLI) is a new endoscopic imaging technique that uses the excitation of blue light to improve detection of EAC in BE patients. The BLI technique is incorporated in the newest FUJIFILM endoscopy systems, as well as WLE. The aim of this study is to find out whether BLI improves detection of BE before endoscopic resection (a procedure to remove the abnormal tissue).
Who can participate?
Patients aged over 18 with BE referred for endoscopy and likely to require endoscopic resection
What does the study involve?
During endoscopy, corresponding WLE and BLI endoscopic images are collected. After the procedure, these images are stored in a database and examined by six international experts.
What are the possible benefits and risks of participating?
The results of this study might in future improve endoscopy for BE patients with EAC. There are no extra risks of participation.
Where is the study run from?
1. Academic Medical Center (Netherlands)
2. Catharina Hospital Eindhoven (Netherlands)
3. University Hospital Leuven (Belgium)
When is the study starting and how long is it expected to run for?
January 2015 to January 2018
Who is funding the study?
1. FUJIFILM Europe
2. Academic Medical Center (Netherlands)
Who is the main contact?
Jeroen de Groof
a.j.degroof@amc.uva.nl
Trial website
Contact information
Type
Scientific
Primary contact
Mr Jeroen de Groof
ORCID ID
Contact details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)205664571
a.j.degroof@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Blue light imaging has an additional value to white light endoscopy in visualization of early Barrett’s neoplasia: an international multicenter cohort study
Acronym
BLI study
Study hypothesis
Blue Light Imaging (BLI) has additional value in overview and in magnification for the use of characterization and delineation of early neoplastic Barrett’s lesions compared to White Light Endoscopy (WLE).
Ethics approval
The Medical Research Involving Human Subjects Act did not apply to this study. Official approval of this study was therefore waived by the Medical Ethics Review Committees of all participating centers (AMC Amsterdam, Catharina Hospital Eindhoven, University Hospital Leuven)
Study design
Multicenter prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Barrett's neoplasia
Intervention
Multiple corresponding overview- and magnification WLE and BLI endoscopic images of BE neoplasia are collected. Subsequently these images are scored and delineated by six international experts using an proprietary online module.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. Experts’ appreciation of macroscopic appearance and surface relief, measured using VAS scores in the first two assessment phases, each separated by a wash-out period of 2 weeks: Phase 1: WLE images only; Phase 2: BLI images only
2. Experts’ ability to delineate the lesion, measured using VAS scores in the first two assessment phases, each separated by a wash-out period of 2 weeks: Phase 1: WLE images only; Phase 2: BLI images only
3. Experts’ preferred technique for macroscopic appearance + surface relief and preferred technique for delineation, measured using ordinal scores in assessment phase 3 (WLE+BLI images), separated from the second assessment phase with a wash-out period of two weeks
Secondary outcome measures
Experts’ quantitative agreement on lesion delineations, measured using AND/OR scores in all three separate assessment phases, each separated by a wash-out period of 2 weeks: Phase 1: WLE images only; Phase 2: BLI images only; Phase 3: WLE+BLI images
Overall trial start date
01/01/2015
Overall trial end date
01/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age > 18 years
2. Patients with BE referred for endoscopic work-up of HGD or EAC likely to require endoscopic resection (EMR or ESD)
3. Lesions can be completely visualized in a single endoscopic image in overview
4. Lesions in which a type 0-II lesion is the dominant part (the more subtle lesions)
5. Eligible for EMR or ESD
6. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Prior history of surgical or endoscopic treatment for oesophageal neoplasia
2. Presence of erosive esophagitis (Los Angeles classification ≥A)
3. Inability to undergo EMR/ESD and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices)
Recruitment start date
04/09/2015
Recruitment end date
07/06/2017
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Trial participating centre
Catharina Hospital Eindhoven
Michelangelolaan 2
Eindhoven
5623 EJ
Netherlands
Trial participating centre
University Hospital Leuven
Herestraat 49
Leuven
3000 Leuven
Belgium
Funders
Funder type
Industry
Funder name
FUJIFILM Europe
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academisch Medisch Centrum
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Study protocol and statistical analyses will not be made available. Planned publication of the results in a high-impact peer reviewed journal.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/04/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list