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ETMI versus Chromoendoscopy in UC


- candidate number15074
- NTR NumberNTR4062
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jul-2013
- Secondary IDsMETC 2012_362 NL42930.018.12
- Public TitleETMI versus Chromoendoscopy in UC
- Scientific TitleEndoscopic trimodal imaging vs. chromoendoscopy as surveillance strategy for neoplasia in ulcerative colitis
- ACRONYMFIND-UC
- hypothesisCE and AFI are equally effective for the detection of neoplastic lesions in patients undergoing colonoscopic surveillance for UC. Also, the combined use of AFI plus NBI and the use of CE have an equal sensitivity and specificity for the differentiation of non-neoplastic and neoplastic mucosa.
- Healt Condition(s) or Problem(s) studiedColonic neoplasia, Longstanding ulcerative colitis
- Inclusion criteria- History of UC
- Longstanding disease: extensive colitis >8 years (Montreal E3); or left-sided colitis >15 years (Montreal E2)
- Age >18 years
- Exclusion criteria- Change in bowel habits in the preceding two months (under maintenance therapy)
- Personal history of (partial) colectomy
- Clinically unfit for colonoscopy
- Proven genetic predisposition for colorectal cancer
- Currently known colonic neoplasia (e.g. referred patients or patients who refused treatment) - Known non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2; or platelet count <50*109), severe cardiopulmonary disease or renal failure)
- At introduction Mayo-score >1 in at least one of the bowel segments
- Poor bowel preparation (scoring <6 points on the Boston Bowel Preparation Scale) (24)
- No informed consent
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2013
- planned closingdate1-aug-2014
- Target number of participants210
- InterventionsIn this RCT we are comparing ETMI (endoscopic tri modal imaging) with chromoendoscopy in the detection of colonic neoplasia in ulcerative colitis. ETMI is a new endoscopy technique where three types of techniques are incorporated in one device: white light endoscopy, narrow band imaging and autofluorescence imaging. Chromoendoscopy is the technique that nowadays is recommended in IBD (Inflammatory bowel disease) surveillance guidelines. This technique makes use of dye spray to enhance the surface of the colonic mucosa, which is time-consuming. There is data that ETMI is has similar performance as chromoendoscopy, but these two technique have never been compared in a randomised controlled trial.
- Primary outcome(1) to compare neoplasia detection rates of autofluorescence imaging (AFI) vs. chromoendoscopy (CE) in patients with ulcerative colitis. (2) to define the mean number of neoplastic lesions per patient.
- Secondary outcome(1) to compare endoscopic trimodal imaging (ETMI) vs. chromoendoscopy (CE) for differentiating neoplastic from non-neoplastic mucosa and (2) to identify diagnostic endoscopic and pathological markers for differentiation between inflammatory dysplasia, that harbour a significant risk on metachronous dysplasia and cancer and might require proctocolectomy, and a sporadic dysplastic lesion that can be safely removed by endoscopic resection.
- TimepointsThis multicenter trial will include 210 patients with longstanding ulcerative colitis. We are aiming to include the last patient one year after the start of the study (August 2014). It will take approximately three months time to analyze the data.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD Evelien Dekker
- CONTACT for SCIENTIFIC QUERIESMD, PhD fellow L.K. Wanders
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Olympus Medical Systems
- PublicationsN/A
- Brief summaryRandomized trial: consecutive patients with longstanding UC will be randomized to undergo surveillance colonoscopy with either ETMI or CE.
- Main changes (audit trail)
- RECORD4-jul-2013 - 24-jul-2013


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