Transient Elastography in Autoimmune Hepatitis

Not Applicable

Completed

• Conditions: Liver Cirrhosis
• Interventions: Device: Transient elastography (TE); Other: Liver biopsy

• Registration Number: NCT01905254
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2010-08
• Study Completion: 2013-01
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-23
• Results First Submitted: 2014-12-07
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-04
• Last Update Submitted: 2015-05-04
• Results First Posted: 2015-05-06
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

• morbid obesity (BMI > 40),
• ascites, ileus or subileus,
• peritonitis,
• pregnancy,
• extrahepatic cholestasis and
• a severe inflammatory flare of AIH.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transient elastography and liver biopsy	Liver biopsy	All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy
Transient elastography and liver biopsy	Transient elastography (TE)	All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis	Transient Elastography compared to liver histology	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.

Trial Locations

Locations (1)

Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf; 🇩🇪 Hamburg, Germany