Contact information
Type
Scientific
Primary contact
Dr Evelien Dekker
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Gastroenterology and Hepatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3632
E.Dekker@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
EVE II study
Study hypothesis
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
Approval received from the Medisch Ethische Commissie (Medical Ethical Commitee) AMC on the 13th December 2006 (ref: MEC06/279 #06.17.1730).
Study design
Randomised, controlled, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Ulcerative colitis
Intervention
NBI-Colonoscopy and WLE-colonoscopy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Number of patients with detected neoplasia.
Secondary outcome measures
1. Number of neoplastic lesions
2. Pit pattern classification (Kudo) of neoplastic lesions
3. Vascular pattern description of neoplastic lesions
Overall trial start date
13/12/2006
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
49
Participant exclusion criteria
1. Age less than 18 years
2. Non-correctable coagulopathy
Recruitment start date
13/12/2006
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (AMC) (The Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
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