The use of narrow band imaging versus conventional colonoscopy for the detection of dysplasia and cancer in patients with longstanding ulcerative colitis: a randomised cross-over study
| ISRCTN | ISRCTN56671833 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56671833 |
| Protocol serial number | NL839, NTR853 |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | Academic Medical Center (AMC) (The Netherlands) |
- Submission date
- 22/01/2007
- Registration date
- 22/01/2007
- Last edited
- 15/01/2021
- 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 Evelien Dekker
Scientific
Scientific
Academic Medical Center (AMC)
Department of Gastroenterology and Hepatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 3632 |
|---|---|
| E.Dekker@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The use of narrow band imaging versus conventional colonoscopy for the detection of dysplasia and cancer in patients with longstanding ulcerative colitis: a randomised cross-over study |
| Study acronym | EVE II study |
| Study objectives | Aim: to compare Narrow Band Imaging (NBI) and standard White Light Endoscopy (WLE) for the detection of neoplasia during colonoscopic surveillance of patients with longstanding Ulcerative Colitis (UC). |
| Ethics approval(s) | Approval received from the Medisch Ethische Commissie (Medical Ethical Commitee) AMC on the 13th December 2006 (ref: MEC06/279 #06.17.1730). |
| Health condition(s) or problem(s) studied | Ulcerative colitis |
| Intervention | NBI-Colonoscopy and WLE-colonoscopy. |
| Intervention type | Other |
| Primary outcome measure(s) |
Number of patients with detected neoplasia. |
| Key secondary outcome measure(s) |
1. Number of neoplastic lesions |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 49 |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. Objective diagnosis of UC (histologically and/or endoscopically) 2. Extensive UC (proximal to splenic flexure) 3. Disease duration more than eight years 4. Inactive disease (Truelove Witts Index less than two) 5. Informed consent |
| Key exclusion criteria | 1. Age less than 18 years 2. Non-correctable coagulopathy |
| Date of first enrolment | 13/12/2006 |
| Date of final enrolment | 01/07/2008 |
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 | 01/03/2007 | 15/01/2021 | Yes | No |
Editorial Notes
15/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
