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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


- candidate number2398
- NTR NumberNTR867
- ISRCTNISRCTN91816824
- Date ISRCTN created1-feb-2007
- date ISRCTN requested28-jan-2007
- Date Registered NTR8-jan-2007
- Secondary IDsN/A 
- Public TitleETMI 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 TitleETMI 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
- ACRONYMGETMI
- hypothesisETMI 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) studiedBarrett's esophagus
- Inclusion criteria1. Barrett's esophagus patients with low-grade dyplasia comfirmed by two expert GI pathologists; 2. Written informed consent
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type-
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate31-dec-2008
- Target number of participants96
- InterventionsETMI-gastroscopy and standard video gastroscopy
- Primary outcome1. Number of patients with early neoplasia detected with ETMI or SVE; 2. Number of lesions with early neoplasia detected with ETMI and SVE.
- Secondary outcome1. Number of early neoplastic lesions detected with AFI only; 2. Reduction of false positives findings after detailed NBI evaluation.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. J.J.G.H.M. Bergman
- CONTACT for SCIENTIFIC QUERIESProf. 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
- PublicationsN/A
- Brief summaryEndoscopic 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)
- RECORD8-jan-2007 - 7-feb-2007


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