Video AutoFluorescence Imaging (AFI) for dysplasia and cancer in patients with Longstanding Ulcerative Colitis (UC)
| ISRCTN | ISRCTN05272746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05272746 |
| Secondary identifying numbers | NTR498 |
- 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
| Study design | Randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | The value of AFI in patients with UC for detection of dysplasia or cancer. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 13/04/2005 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Gastroenterology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (The Netherlands)
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 | 01/08/2008 | Yes | No |
