Transient Elastography in Autoimmune Hepatitis
Recent, research has focused on the evaluation of non-invasive methods for the assessment of liver fibrosis in patients with chronic liver disease. Among these methods, transient elastography is the most promising. The method has been investigated mainly in patients with viral hepatitis. Several studies have shown, that the optimal cut-off value of TE for detection of liver cirrhosis by transient elastography is highly dependent on the aetiology of the underlying liver disease. Only a few studies have evaluated the value of transient elastography for patients with autoimmune liver disease and here primarily patients with PBC and PSC. For patients with autoimmune hepatitis the data is limited. We prospectively investigated the diagnostic accuracy of TE in autoimmune hepatitis compared to liver histology with and without inclusion of the macroscopic appearance using mini-laparoscopy
|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||University Clinic Hamburg Eppendorf|
|Study Chair:||Ansgar W Lohse, MD||University Clinic Hamburg Eppendorf|