|- candidate number||24435|
|- NTR Number||NTR5924|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-jun-2016|
|- Secondary IDs||16/CEN/81 // 2016.316 Health and Disability Ethics Commitee in Nieuw-Zeeland// METC VU|
|- Public Title||FIbroscan To detect LIVER fibrosis in patients with inflammatory bowel disease receiving long-term thiopurine therapy|
|- Scientific Title||FIbroscan To detect LIVER fibrosis in patients with inflammatory bowel disease receiving long-term thiopurine therapy|
|- hypothesis||Inflammatory Bowel Disease patients using thiopurines are at higher risk of developing liver abnormalities than IBD patients without thiopurine exposure.|
|- Healt Condition(s) or Problem(s) studied||Inflammatory bowel disease, Liver cirrhosis|
|- Inclusion criteria||Adult patients (>18 y/o)|
Diagnosed with inflammatory bowel disease (i.e. Crohn’s disease, ulcerative colitis or IBD unclassified)
|- Exclusion criteria||Concomitant known liver pathology (e.g. viral hepatitis, liver cancer, liver cirrhosis, liver fibrosis) |
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2016|
|- planned closingdate||31-aug-2017|
|- Target number of participants||0|
|- Interventions||Fibroscan: Also called transient elastography, used to assess liver stiffness (measured in kPa) without invasive investigation.
|- Primary outcome||Liver stiffness score (Metavir), F0-F4|
|- Secondary outcome||N/A|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD-student B. Meijer|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD-student B. Meijer|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Inflammatory Bowel Disease (IBD) comprises two chronic conditions of the gastrointestinal tract, namely Crohn's disease and ulcerative colitis. These diseases are characterized by episodes of remissions and relapses, causing significant decreases in quality of life and thus emphasizing the need of drugs maintaining remission. The first-step in maintaining remission is the administration of thiopurines (i.e. azathioprine and mercaptopurine). [Dignass, 2010; 2012] One of the concerns of this therapy is the alleged risk of associated liver pathology. [Dubinsky, 2003; Vernier-Massouille, 2007].
According to a database study in 2007, liver test (LT) abnormalities occur in up to 16% of IBD-patients, regardless of therapy or concomitant diagnoses. Interestingly, only 42% of these LT abnormalities could be linked to thiopurine use, leaving at least 58% of LT abnormalities caused by other reasons than thiopurine therapy. [Gisbert, 2007].
In other literature reports, thiopurine use is linked to various liver abnormalities, such as sinusoidal obstructive syndrome (SOS), nodular regenerative hyperplasia (NRH), liver cirrhosis, liver fibrosis or non-cirrhotic portal hypertension (NCPH). [Dubinsky, 2003; Vernier-Massouille, 2007; Suárez-Ferrer, 2015; Jharap, 2015]. These diagnoses were assessed primarily by liver biopsy, which is an invasive procedure.
Using a Fibroscan, fibrosis of the liver might be measured using a non-invasive procedure. In previous studies, fibroscan measurements seemed to correlate with results from liver biopsies in a large number of patients [Muñoz, 2009; Goyal, 2013].
|- Main changes (audit trail)|
|- RECORD||2-jun-2016 - 8-aug-2016|