Endoscopic Tri-Modal Imaging for the detection of early neoplasia in patients with Barrett's oesophagus in tertiary referral Centres: a randomised cross-over multicentre study
| ISRCTN | ISRCTN68328077 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68328077 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 05/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Scientific
Academic Medical Centre (AMC)
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5663556 |
|---|---|
| j.j.bergman@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, multicentre, crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study acronym | ETMIC |
| Study objectives | Endoscopic Tri-Modal Imaging (ETMI) improves the detection of early neoplasia in Barrett's oEsophagus (BE). |
| Ethics approval(s) | Approval received from the Medical Ethical Commission of the Academic Medical Centre on the 18th January 2007 (ref: MEC 06/292). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2007 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 84 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Hepato- and Gastro-enterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/index.cfm?sid=818 |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Industry
Olympus Corporation (Japan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2007 | Yes | No | |
| Results article | results | 01/10/2010 | Yes | No |
