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Transient Elastography in Autoimmune Hepatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PD Dr. med. Ulrike Denzer, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01905254
First received: July 1, 2013
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Liver Cirrhosis
Device: Transient elastography (TE)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Diagnostic accuracy of Transient elastography in fibrosis staging [ Time Frame: Transient Elastography compared to liver histology up to 3 months ] [ Designated as safety issue: No ]

    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

    1. Histopathologic examination and
    2. Macroscopic appearance on minilaparoscopy combined with liver histology.


Enrollment: 34
Study Start Date: August 2007
Study Completion Date: January 2013
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TE diagnosis of fibrosis in AIH
All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography (TE) and minilaproscopic liver biopsy for fibrosis stage
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.

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

  1. histopathologic examination and
  2. macroscopic appearance on minilaparoscopy combined with liver histology 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905254

Locations
Germany
Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Ulrike W Denzer, MD University Clinic Hamburg Eppendorf
Study Chair: Ansgar W Lohse, MD University Clinic Hamburg Eppendorf
  More Information

No publications provided

Responsible Party: PD Dr. med. Ulrike Denzer, Attending physician, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01905254     History of Changes
Other Study ID Numbers: UKE IRB 2742
Study First Received: July 1, 2013
Last Updated: July 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Transient elastography
mini-laparoscopy
liver biopsy
liver cirrhosis
autoimmune hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Autoimmune
Liver Cirrhosis
Autoimmune Diseases
Digestive System Diseases
Hepatitis, Chronic
Immune System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on November 19, 2014