Transient Elastography in Autoimmune Hepatitis
Primary Purpose
Liver Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transient elastography (TE)
Liver biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Cirrhosis focused on measuring Transient elastography, mini-laparoscopy, liver biopsy, liver cirrhosis, autoimmune hepatitis
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of AIH based on the diagnostic criteria revised by the International Autoimmune Hepatitis Group 2008 (20):
- liver related autoantibodies,
- hypergammaglobulinaemia,
- typical histological findings and
- 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.
Sites / Locations
- Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Transient elastography and liver biopsy
Arm Description
All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy
Outcomes
Primary Outcome Measures
Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01905254
First Posted
July 1, 2013
Last Updated
May 4, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT01905254
Brief Title
Transient Elastography in Autoimmune Hepatitis
Official Title
Prospective Comparison of Transient Elastography and Mini-laparoscopic Guided Liver Biopsy in Autoimmune Hepatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Transient elastography, mini-laparoscopy, liver biopsy, liver cirrhosis, autoimmune hepatitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transient elastography and liver biopsy
Arm Type
Other
Arm Description
All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy
Intervention Type
Device
Intervention Name(s)
Transient elastography (TE)
Intervention Description
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
Other
Intervention Name(s)
Liver biopsy
Intervention Description
Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography
Primary Outcome Measure Information:
Title
Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis
Description
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.
Time Frame
Transient Elastography compared to liver histology
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of AIH based on the diagnostic criteria revised by the International Autoimmune Hepatitis Group 2008 (20):
liver related autoantibodies,
hypergammaglobulinaemia,
typical histological findings and
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike W Denzer, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ansgar W Lohse, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
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Transient Elastography in Autoimmune Hepatitis
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