No registrations found.
ID
Source
Brief title
Health condition
Longstanding ulcerative colitis, colonic neoplasia
Langdurige colitis ulcerosa, dikkedarm neoplasieën
Sponsors and support
Intervention
Outcome measures
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.
Background summary
Randomized trial: consecutive patients with longstanding UC will be randomized to undergo surveillance colonoscopy with either ETMI or CE.
Study objective
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.
Study design
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.
Intervention
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.
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
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3900 |
| NTR-old | NTR4062 |
| Other | NL42930.018.12 : METC 2012_362 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |