Contact information
Type
Scientific
Primary contact
Dr Jacques Bergman
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3556
j.j.bergman@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
GETMI
Study hypothesis
Endoscopic Tri-Modal Imaging (ETMI) increases the detection rate of early neoplasia in Barrett's oEsophagus (BE) patients with 40% or more compared to Standard Video Endoscopy (SVE).
Ethics approval
Approval received from the local medical ethics committee on the 10th August 2006 (ref: MEC 05/068).
Study design
Randomised, crossover multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Barrett's oesophagus
Intervention
ETMI-gastroscopy and standard video gastroscopy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
1. Number of early neoplastic lesions detected with AutoFluorescence Imaging (AFI) only
2. Reduction of false positives findings after detailed Narrow Band Imaging (NBI) evaluation
Overall trial start date
01/01/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Barrett's oesophagus patients with low-grade dyplasia comfirmed by two expert GastroIntestinal (GI) pathologists
2. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
96
Participant exclusion criteria
1. Presence of active erosive oesophagitis grade A according to the Los Angeles classification of erosive oesophagitis
2. Presence of conditions precluding histological sampling of the oesophagus (e.g. oesophageal varices, coagulation disorders, anticoagulant therapy)
3. Less than 18 years
Recruitment start date
01/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21168835
Publication citations
-
Results
Curvers WL, van Vilsteren FG, Baak LC, Böhmer C, Mallant-Hent RC, Naber AH, van Oijen A, Ponsioen CY, Scholten P, Schenk E, Schoon E, Seldenrijk CA, Meijer GA, ten Kate FJ, Bergman JJ, Endoscopic trimodal imaging versus standard video endoscopy for detection of early Barrett's neoplasia: a multicenter, randomized, crossover study in general practice., Gastrointest. Endosc., 2011, 73, 2, 195-203, doi: 10.1016/j.gie.2010.10.014.