Transient Elastography in Autoimmune Hepatitis

NCT ID: NCT01905254

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2013-01-31

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Transient elastography and liver biopsy

All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy

Group Type: OTHER

Transient elastography (TE)

Intervention Type: DEVICE

TE and minilaparoscopic guided liver biopsy were performed by physicians blinded to the results the other within a period of less than 3 months.

Liver biopsy

Intervention Type: OTHER

Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography

Interventions

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.

Intervention Type: DEVICE

Liver biopsy

Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. med. Ulrike Denzer

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrike W Denzer, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Ansgar W Lohse, MD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Locations

Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf

Hamburg, City state of Hamburg, Germany

Countries

Germany

Other Identifiers

UKE IRB 2742

Identifier Type: -

Identifier Source: org_study_id