Blue light imaging has an additional value to white light endoscopy in visualization of early Barrett’s neoplasia: an international multicenter cohort study
| ISRCTN | ISRCTN15916689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15916689 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/02/2018
- Registration date
- 19/02/2018
- Last edited
- 04/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)205664571 |
|---|---|
| a.j.degroof@amc.uva.nl |
Study information
| Study design | Multicenter prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | BLI study |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/01/2015 |
| Completion date | 01/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 04/09/2015 |
| Date of final enrolment | 07/06/2017 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centres
Amsterdam
1105 AZ
Netherlands
Eindhoven
5623 EJ
Netherlands
Leuven
3000 Leuven
Belgium
Sponsor information
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Funders
Funder type
Industry
No information available
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | 23/11/2020 | Yes | No |
| Protocol file | 04/10/2022 | No | No |
Additional files
Editorial Notes
04/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
23/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
