Video AutoFluorescence Imaging (AFI) for dysplasia and cancer in patients with Longstanding Ulcerative Colitis (UC)
| ISRCTN | ISRCTN05272746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05272746 |
| Protocol serial number | NTR498 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 09/01/2006
- Registration date
- 09/01/2006
- Last edited
- 18/07/2008
- 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 E. Dekker
Scientific
Scientific
Academic Medical Center
Department of Gastroenterohepatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| E.Dekker@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | AFILUC Study |
| Study objectives | The aims of the study are: 1. To assess the clinical utility and feasibility of autofluorescence imaging (AFI) in surveillance colonoscopy in patients with longstanding ulcerative colitis (UC) 2. To determine the additional value of AFI in the detection of dysplasia and cancer in these patients 3. To characterise the surface patterns in normal and neoplastic areas in these patients by using narrow band imaging (NBI) |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Ulcerative colitis |
| Intervention | Patients undergoing surveillance colonoscopy with endoscopic tri-modal imaging (ETMI) received inspections of their colonic segments using: 1. Autofluorescence imaging (AFI) 2. White light endoscopy (WLE) Each patient received both inspections in a random order. |
| Intervention type | Other |
| Primary outcome measure(s) | The value of AFI in patients with UC for detection of dysplasia or cancer. |
| Key secondary outcome measure(s) | No secondary outcome measures |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Objective diagnosis of UC 2. History of pancolitis 3. Inactive disease determined by a Disease Activity Index |
| Key exclusion criteria | 1. Known history of colorectal cancer 2. Severe coagulopathy 3. Age less than 18 years |
| Date of first enrolment | 13/04/2005 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
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 | 01/08/2008 | Yes | No |
