N/A
Completed N=34
Transient Elastography in Autoimmune Hepatitis
Source: ClinicalTrials.gov NCT01905254 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis — 0.83; 1.00; 1.00; 0.97 Probability
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis |
0.83; 1.00; 1.00; 0.97 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01905254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.