No registrations found.
ID
Source
Brief title
Health condition
Barrett's neoplasia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Delineation scores:
a) Percentage of the ground truth delineation delineated;
b) AND/OR score for the ground truth delineation;
c) Difference in delineation scores for different levels of endoscopic experience;
VAS- and ordinal scores for assessment per lesion:
a) Characterization (Paris classification and surface relief);
b) Delineation;
c) Difference in scores for different levels of endoscopic experience;
Secondary outcome
See above
Background summary
A recent study performed by our group showed additional value for BLI for the visualization of BE neoplasia, when assessed by experts. Experts appreciated BLI better than WLE for visualization and delineation of BE neoplasia. Furthermore, their quantitative agreement increased significantly when BLI was offered next to WLE for lesions that were hard to delineate with WLE alone.
The aim of this study is to evaluate BLI and LCI as an additional tool next to WLE for the use of visualization and delineation of early Barrett neoplasia, when used by endoscopists with different levels of endoscopic expertise.
Study objective
Blue Light Imaging (BLI) and Linked Color Imaging (LCI) have additional value for the visualization of Barrett's neoplasia, when compared to White Light Endoscopy (WLE).
Study design
This study is divided in 4 separate assessment phases, in which the endoscopic images will be scored and delineated by the assessors. Each phase is separated by a wash-out period of 2 weeks.
Phase 1: Only WLE images are shown (n=30)
Phase 2: WLE and BLI images are shown (n=15), WLE and LCI images are shown (n=15)
Phase 3: WLE and LCI images are shown (n=15), WLE and BLI images are shown (n=15)
Phase 4: WLE, BLI and LCI images are shown (n=30)
Intervention
n.a.
Jeroen de Groof
+31 20 5664571
a.j.degroof@amc.uva.nl
Jeroen de Groof
+31 20 5664571
a.j.degroof@amc.uva.nl
Inclusion criteria
Data from our previous study will be used (doi: 10.1016/j.gie.2018.10.046.). No new patient data will be collected.
A group of 90 international endoscopist assessors (30 fellows, 30 junior GE, 30 senior GE) will assess the endoscopic images collected in the previous study.
Exclusion criteria
Data from our previous study will be used (doi: 10.1016/j.gie.2018.10.046.). No new patient data will be collected.
A group of 90 international endoscopist assessors (30 fellows, 30 junior GE, 30 senior GE) will assess the endoscopic images collected in the previous study.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7541 |
| Other | METC AMC : W15_068 |