Condition category
Cancer
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
05/11/2010
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 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

http://www.amc.uva.nl/index.cfm?sid=818

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

  1. Results

    Rösch T, Highlights of United European Gastroenterology Week 2006., Endoscopy, 2007, 39, 3, 238-246, doi: 10.1055/s-2007-966293.

  2. 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.

Additional files

Editorial Notes