Blue light imaging has an additional value to white light endoscopy in visualization of early Barrett’s neoplasia: an international multicenter cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15916689

Enrollment

Registered

2018-02-19

Start date

2015-09-04

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's neoplasia Digestive System Barrett oesophagus

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026