Liver Cirrhosis
Conditions
Keywords
Transient elastography, mini-laparoscopy, liver biopsy, liver cirrhosis, autoimmune hepatitis
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.
Interventions
OTHERLiver biopsy
Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography
TE and minilaparoscopic guided liver biopsy were performed by physicians blinded to the results the other within a period of less than 3 months.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis | 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. |
Countries
Germany
Participant flow
Pre-assignment details
Thirty-nine patients with AIH were eligible during the study period. Five patients were excluded: 4 patients due to ineffective or incomplete (\<60% success rate) liver stiffness measurement, and 1 patient with a severe acute flare of AIH with markedly elevated liver enzymes.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Single Arm Study |
|---|---|
| Age, Continuous | 53 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment Germany | 34 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
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
Population: Sensitivity, specifity; Positive and negative predictive value of TE for diagnosis of cirrhosis was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transient Elastography in Autoimmune Hepatitis | Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis | Positive predictive value of TE for cirrhosis | 1.00 Probability |
| Transient Elastography in Autoimmune Hepatitis | Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis | Sensitivity of TE for diagnosis cirrhosis | 0.83 Probability |
| Transient Elastography in Autoimmune Hepatitis | Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis | Specifity of TE for diagnosis cirrhosis | 1.00 Probability |
| Transient Elastography in Autoimmune Hepatitis | Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis | Negative predictive value of TE for cirrhosis | 0.97 Probability |