CE 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…
ID
Bron
Verkorte titel
Aandoening
Longstanding ulcerative colitis, colonic neoplasia
Langdurige colitis ulcerosa, dikkedarm neoplasieën
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
(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.
Achtergrond van het onderzoek
Randomized trial: consecutive patients with longstanding UC will be randomized to undergo surveillance colonoscopy with either ETMI or CE.
Doel van het onderzoek
CE 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.
Onderzoeksopzet
This 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.
Onderzoeksproduct en/of interventie
In 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.
Publiek
Department of Gastroenterology and Hepatology <br>
P.O. Box 22660
Evelien Dekker
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664702
e.dekker@amc.uva.nl
Wetenschappelijk
Department of Gastroenterology and Hepatology <br>
P.O. Box 22660
Evelien Dekker
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664702
e.dekker@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- History of UC
- Longstanding disease: extensive colitis >8 years (Montreal E3); or left-sided colitis >15 years (Montreal E2)
- Age >18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3900 |
NTR-old | NTR4062 |
Ander register | NL42930.018.12 : METC 2012_362 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |