Condition category
Digestive System
Date applied
15/02/2018
Date assigned
19/02/2018
Last edited
16/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Academic Medical Center Amsterdam

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes