| - candidate number | 2398 |
| - NTR Number | NTR867 |
| - ISRCTN | ISRCTN91816824 |
| - Date ISRCTN created | 1-feb-2007 |
| - date ISRCTN requested | 28-jan-2007 |
| - Date Registered NTR | 8-jan-2007 |
| - Secondary IDs | N/A |
| - Public Title | ETMI vs. standard video endoscopy for the detection of early neoplasia in patients with low-grade dysplasia in a Barrett's esophagus: a multi-center randomized cross-over controlled study |
| - Scientific Title | ETMI vs. standard video endoscopy for the detection of early neoplasia in patients with low-grade dysplasia in a Barrett's esophagus: a multi-center randomized cross-over controlled study |
| - ACRONYM | GETMI |
| - hypothesis | ETMI increases the detection rate of early neoplasia in BE patients with 40% or more compared to standard video endoscopy |
| - Healt Condition(s) or Problem(s) studied | Barrett's esophagus |
| - 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 |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Not applicable |
| - group | Crossover |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-jan-2007 |
| - planned closingdate | 31-dec-2008 |
| - Target number of participants | 96 |
| - Interventions | ETMI-gastroscopy and standard video gastroscopy |
| - 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. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Prof. dr. J.J.G.H.M. Bergman |
| - CONTACT for SCIENTIFIC QUERIES | Prof. dr. J.J.G.H.M. Bergman |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Gastroenterology |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 8-jan-2007 - 7-feb-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl