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
Secondary identifying numbers	NL839, NTR853

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

Academic Medical Center (AMC)
Department of Gastroenterology and Hepatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 3632
Email	E.Dekker@amc.uva.nl

Study information

Study design	Randomised, controlled, crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	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 study start date	13/12/2006
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	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

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)

Alternative name(s): Academic Medical Center, AMC
Location: Netherlands

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	01/03/2007	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.