Transient Elastography in Autoimmune Hepatitis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Prospective Comparison of Transient Elastography and Mini-laparoscopic Guided Liver Biopsy in Autoimmune Hepatitis|
- Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis [ Time Frame: Transient Elastography compared to liver histology ] [ Designated as safety issue: No ]The aim of the current study was to assess the diagnostic accuracy (Sens., Spec.) of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis. TE was compared to the diagnosis of cirrhosis made on histology yielded by laparoscopic guided liver biopsy.
|Study Start Date:||August 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Transient elastography and liver biopsy
All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy
Device: Transient elastography (TE)
TE and minilaparoscopic guided liver biopsy were performed by physicians blinded to the results the other within a period of less than 3 months.Other: Liver biopsy
Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography
The aim of the current study was to assess the diagnostic performance of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis compared to the diagnosis of cirrhosis made on Laparoscopic guided liver biopsy. Patients referred for liver biopsy and transient elastography with a clinical diagnosis of AIH followed in the liver clinic of the Department of Gastroenterology at the UKE were prospectively included in the study.
Inclusion criteria were as follows: Confirmed diagnosis of AIH based on the diagnostic criteria revised by the International Autoimmune Hepatitis Group 2008 (20): 1. liver related autoantibodies, 2. hypergammaglobulinaemia, 3.typical histological findings and 4. absence of viral markers. Exclusion criteria were morbid obesity (BMI > 40), ascites, ileus or subileus, peritonitis, pregnancy, extrahepatic cholestasis and a severe inflammatory flare of AIH.
Blood liver tests including gamma-globulines, IgG, IgM, liver related autoantibodies (ANA, AMA, LKM, SMA, SLA) and viral markers (HBsAg, Anti HBs, Anti HBc, Anti HCV, Anti HAV) were performed before LB.
Each patient underwent abdominal ultrasound to exclude extrahepatic cholestasis prior to TE and minilaparoscopic liver biopsy. TE and minilaparoscopy were performed by physicians blinded to the results the other within a period of less than 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905254
|Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Ulrike W Denzer, MD||Universitätsklinikum Hamburg-Eppendorf|
|Study Chair:||Ansgar W Lohse, MD||Universitätsklinikum Hamburg-Eppendorf|