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 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- 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
Scientific
Academic Medical Center (AMC)
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 3556 |
|---|---|
| j.j.bergman@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, crossover multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GETMI |
| Study objectives | 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(s) | Approval received from the local medical ethics committee on the 10th August 2006 (ref: MEC 05/068). |
| Health condition(s) or problem(s) studied | Barrett's oesophagus |
| Intervention | ETMI-gastroscopy and standard video gastroscopy |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Number of patients with early neoplasia detected with ETMI or SVE |
| Key secondary outcome measure(s) |
1. Number of early neoplastic lesions detected with AutoFluorescence Imaging (AFI) only |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 96 |
| Key inclusion criteria | 1. Barrett's oesophagus patients with low-grade dyplasia comfirmed by two expert GastroIntestinal (GI) pathologists 2. Written informed consent |
| Key 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 |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/02/2011 | Yes | No |
