Endoscopic Tri-Modal Imaging versus standard video endoscopy for the detection of early neoplasia in patients with low-grade dysplasia in a Barrett's oesophagus: a multicentre randomised cross-over controlled study

ISRCTN ISRCTN91816824
DOI https://doi.org/10.1186/ISRCTN91816824
Secondary identifying numbers N/A
Submission date
01/02/2007
Registration date
01/02/2007
Last edited
04/07/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jacques Bergman
Scientific

Academic Medical Center (AMC)
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 566 3556
Email j.j.bergman@amc.uva.nl

Study information

Study designRandomised, crossover multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymGETMI
Study objectivesEndoscopic 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(s)Approval received from the local medical ethics committee on the 10th August 2006 (ref: MEC 05/068).
Health condition(s) or problem(s) studiedBarrett's oesophagus
InterventionETMI-gastroscopy and standard video gastroscopy
Intervention typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/01/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants96
Key inclusion criteria1. Barrett's oesophagus patients with low-grade dyplasia comfirmed by two expert GastroIntestinal (GI) pathologists
2. Written informed consent
Key exclusion criteria1. 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
Date of first enrolment01/01/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2011 Yes No