No registrations found.
ID
Source
Brief title
Health condition
Barrett's esophagus
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Number of patients with early neoplasia detected with ETMI or SVE;
2. Number of lesions with early neoplasia detected with ETMI and SVE.
Secondary outcome
1. Number of early neoplastic lesions detected with AFI only;
2. Reduction of false positives findings after detailed NBI evaluation.
Background summary
Endoscopic Trimodal IMaging is a new imaging device that incorperates high-resolution white light endoscopy with autofluorescence imaging and narrow band imaging. Our aim of this study is to compare ETMI with standard video endoscopy for the detection of early neoplastic lesions in Barrett's esophagus with an intermediate risk profile in a non-expert setting.
Barrett's esophagus patients with confirmed low-grade dysplasia by two expert GI pathologist will undergo ETMI and standard video endoscopy by two different endoscopists from non-university hospitals with no specific expertise in the detection of early neoplastic lesions in Barrett's esophagus.
Study objective
ETMI increases the detection rate of early neoplasia in BE patients with 40% or more compared to standard video endoscopy
Intervention
ETMI-gastroscopy and standard video gastroscopy
Bldg. C2-210, Meibergdreef
J.J.G.H.M. Bergman
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.j.bergman@amc.uva.nl
Bldg. C2-210, Meibergdreef
J.J.G.H.M. Bergman
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.j.bergman@amc.uva.nl
Inclusion criteria
1. Barrett's esophagus patients with low-grade dyplasia comfirmed by two expert GI pathologists;
2. Written informed consent
Exclusion criteria
1. Presence of active erosive esophagitis grade A according to the Los Angles classification of erosive esophagitis;
2. Presence of conditions precluding histological sampling of the esophagus (e.g. esophageal varices, coagulation disorders, anticoagulant therapy);
3. < 18 years
Design
Recruitment
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 | NL853 |
| NTR-old | NTR867 |
| Other | : N/A |
| ISRCTN | ISRCTN91816824 |