Contact information
Type
Scientific
Primary contact
Dr Jacques Bergman
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663556
j.j.bergman@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ETMIC
Study hypothesis
Endoscopic Tri-Modal Imaging (ETMI) improves the detection of early neoplasia in Barrett's oEsophagus (BE).
Ethics approval
Approval received from the Medical Ethical Commission of the Academic Medical Centre on the 18th January 2007 (ref: MEC 06/292).
Study design
Randomised, active controlled, multicentre, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Barrett's oesophagus, autofluorescence imaging, narrow band imaging
Intervention
In this study we will compare diagnostic endoscopy techniques for the detection of early neoplasia in Barrett's oesophagus. These techniques are Standard Video Endoscopy (SVE) (the current standard) and Endoscopic Tri-Modal Imaging (ETMI).
Patients will undergo two consecutive endoscopies in an interval of 8 to 12 weeks. One of the two aforementioned techniques will be randomly assigned to the first procedure; the second procedure will subsequently be performed with the other technique by a second endoscopist.
The primary outcome will be the number of lesions and patients with early neoplasia detected with standard video endoscopy and ETMI.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. The number of patients and the number of lesions with early neoplasia detected with SVE and ETMI
2. The number of patients with early neoplasia detected with targeted biopsies only with ETMI and SVE
Secondary outcome measures
1. The sensitivity and Positive Predictive Value (PPV) of High-Resolution Endoscopy (HRE) and Autofluorescence Imaging (AFI)
2. The reduction of false positive findings after Narrow Band Imaging (NBI)
3. Negative predictive value of the combination of HRE and AFI and the reduction in false negative findings after
Overall trial start date
01/03/2007
Overall trial end date
01/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged greater than 18 years
2. Prior diagnosis of BE defined as the presence of columnar lined epithelium in the tubular oesophagus with specialised intestinal metaplasia on histological investigation
3. Prior diagnosis of high-grade dysplasia or early cancer that was endoscopically inconspicuous according to the referring physician. Review of the pathology slides is not required for inclusion
4. A minimum Barrett's length of C greater than 2M greater than 2 or C less than 2M greater than 4 according to the Prague C&M classification of the endoscopic appearance of BE
5. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
84
Participant exclusion criteria
1. Presence of active erosive oesophagitis greater than grade A according to the Los Angles classification of erosive oesophagitis
2. Description of an endoscopically visible suspicious lesion in the Barrett's segment in the referring centre
3. Presence of conditions precluding histological sampling of the oesophagus (e.g. oesophageal varices, coagulation disorders, anticoagulant therapy)
Recruitment start date
01/03/2007
Recruitment end date
01/09/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Hepato- and Gastro-enterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Olympus Corporation (Japan)
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. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17385109
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20600033
Publication citations
-
Results
Rösch T, Highlights of United European Gastroenterology Week 2006., Endoscopy, 2007, 39, 3, 238-246, doi: 10.1055/s-2007-966293.
-
Results
Curvers WL, Alvarez Herrero L, Wallace MB, Wong Kee Song LM, Ragunath K, Wolfsen HC, Prasad GA, Wang KK, Subramanian V, Weusten BL, Ten Kate FJ, Bergman JJ, Endoscopic tri-modal imaging is more effective than standard endoscopy in identifying early-stage neoplasia in Barrett's esophagus., Gastroenterology, 2010, 139, 4, 1106-1114, doi: 10.1053/j.gastro.2010.06.045.