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van CCT (UK)


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van CCT (UK)


The use of narrow band imaging versus conventional colonoscopy for the detection of dysplasia and cancer in patients with longstanding ulcerative colitis. A randomized cross-over study.


- candidate number2380
- NTR NumberNTR853
- ISRCTNISRCTN56671833
- Date ISRCTN created22-jan-2007
- date ISRCTN requested12-jan-2007
- Date Registered NTR27-dec-2006
- Secondary IDsN/A 
- Public TitleThe use of narrow band imaging versus conventional colonoscopy for the detection of dysplasia and cancer in patients with longstanding ulcerative colitis. A randomized cross-over study.
- Scientific TitleNarrow band imaging for neoplasia detection in patients with longstanding ulcerative colitis.
- ACRONYMEVE II study
- hypothesisAim: 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).
- Healt Condition(s) or Problem(s) studiedEmollients
- Inclusion criteria1. Objective diagnosis of UC (histologically and/or endoscopically); 2. Extensive UC (proximal to splenic flexure); 3. Disease duration > 8 years; 4. Inactive disease (Truelove Witts Index<2); 5. Informed consent.
- Exclusion criteria1. Age < 18 years; 2. Non correctable coagulopathy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type-
- Studytypeintervention
- planned startdate 13-dec-2006
- planned closingdate1-jul-2008
- Target number of participants49
- InterventionsNBI-Colonoscopy and WLE-colonoscopy.
- Primary outcomeNumber of patients with detected neoplasia.
- Secondary outcome1. Number of neoplastic lesions; 2. Pit pattern classification (Kudo) of neoplastic lesions; 3. Vascular pattern description of neoplastic lesions.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Evelien Dekker
- CONTACT for SCIENTIFIC QUERIESMD, PhD Evelien Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryPatients with longstanding UC will undergo colonoscopic surveillance by both WLE and NBI with a time interval of at least 4 weeks between the procedures. Randomization determines the order of the two techniques. During both procedures targeted biopsies will be taken from suspicious lesions. Only during the second procedure additional random biopsies will be taken according to current clinical guidelines. All detected lesions will be inspected and imaged with NBI and the mucosal morphology and vascular pattern will be classified. The histopathological outcome of the biopsies will be used as the gold standard for diagnosis.
- Main changes (audit trail)
- RECORD27-dec-2006 - 23-jan-2007


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