Clinical trial NCT01905254: Transient Elastography in Autoimmune Hepatitis
Official title: Prospective Comparison of Transient Elastography and Mini-laparoscopic Guided Liver Biopsy in Autoimmune Hepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Transient elastography
mini-laparoscopy
liver biopsy
liver cirrhosis
autoimmune hepatitis
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis
timeFrame: Transient Elastography compared to liver histology
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Ulrike W Denzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Ansgar W Lohse, MD
role: STUDY_CHAIR
References: