Condition category
Digestive System
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
23/01/2007
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 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

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

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

Publication citations

Additional files

Editorial Notes