An interventional study of Transient elastography (TE) and Liver biopsy in Liver Cirrhosis, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-06.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Diagnostic
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
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.
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Confirmed diagnosis of AIH based on the diagnostic criteria revised by the International Autoimmune Hepatitis Group 2008 (20):
Exclusion Criteria:
All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy
Device: Transient elastography (TE) · Other: Liver biopsy
TE and minilaparoscopic guided liver biopsy were performed by physicians blinded to the results the other within a period of less than 3 months.
Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography
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.
Time frame: Transient Elastography compared to liver histology
| Milestone | Transient Elastography and Liver Biopsy |
|---|---|
| Started | 34 |
| Completed | 34 |
| Not completed | 0 |
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.
| Probability | Transient Elastography in Autoimmune Hepatitis |
|---|---|
| Sensitivity of TE for diagnosis cirrhosis | 0.83 |
| Specifity of TE for diagnosis cirrhosis | 1.00 |
| Positive predictive value of TE for cirrhosis | 1.00 |
| Negative predictive value of TE for cirrhosis | 0.97 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TE in Autoimmune Hepatitis | — | 0/34 (0%) | 0/34 (0%) |
| Event | TE in Autoimmune Hepatitis |
|---|---|
| Pain after liver biopsyGastrointestinal disorders | 0/34 |
| Bleeding after liver biopsyHepatobiliary disorders | 0/34 |
| Event | TE in Autoimmune Hepatitis |
|---|---|
| HypotensionCardiac disorders | 0/34 |
Data analysis was performed on 34 patients (female: 28 (82%); male: 6 (18 %). Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in.
| Age, Continuous(years) | Single Arm Study |
|---|---|
| Median | 53 (21 to 74) |
| Sex: Female, Male(Participants) | Single Arm Study |
|---|---|
| Female | 28 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Single Arm Study |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 34 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Arm Study |
|---|---|
| Germany | 34 |
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf