Condition category
Digestive System
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
18/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E. Dekker

ORCID ID

Contact details

Academic Medical Center
Department of Gastroenterohepatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
E.Dekker@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR498

Study information

Scientific title

Acronym

AFILUC Study

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The value of AFI in patients with UC for detection of dysplasia or cancer.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

13/04/2005

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Objective diagnosis of UC
2. History of pancolitis
3. Inactive disease determined by a Disease Activity Index

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Known history of colorectal cancer
2. Severe coagulopathy
3. Age less than 18 years

Recruitment start date

13/04/2005

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Gastroenterology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18367559

Publication citations

  1. Results

    van den Broek FJ, Fockens P, van Eeden S, Reitsma JB, Hardwick JC, Stokkers PC, Dekker E, Endoscopic tri-modal imaging for surveillance in ulcerative colitis: randomised comparison of high-resolution endoscopy and autofluorescence imaging for neoplasia detection; and evaluation of narrow-band imaging for classification of lesions., Gut, 2008, 57, 8, 1083-1089, doi: 10.1136/gut.2007.144097.

Additional files

Editorial Notes