Condition category
Digestive System
Date applied
01/02/2007
Date assigned
01/02/2007
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.amc.uva.nl

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21168835

Publication citations

  1. 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.

Additional files

Editorial Notes