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Transient Elastography in Autoimmune Hepatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01905254
First Posted: July 23, 2013
Last Update Posted: May 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PD Dr. med. Ulrike Denzer, Universitätsklinikum Hamburg-Eppendorf
  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) Other: Liver biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (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 PD Dr. med. Ulrike Denzer, Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis [ Time Frame: 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.


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
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

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Universitätsklinikum Hamburg-Eppendorf
Study Chair: Ansgar W Lohse, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

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
First Submitted: July 1, 2013
First Posted: July 23, 2013
Results First Submitted: December 7, 2014
Results First Posted: May 6, 2015
Last Update Posted: May 6, 2015
Last Verified: May 2015

Keywords provided by PD Dr. med. Ulrike Denzer, Universitätsklinikum Hamburg-Eppendorf:
Transient elastography
mini-laparoscopy
liver biopsy
liver cirrhosis
autoimmune hepatitis

Additional relevant MeSH terms:
Hepatitis, Autoimmune
Hepatitis
Fibrosis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Liver Extracts
Hematinics