Prospective Study to Evaluate the Diagnostic Value of B-mode Ultrasound, Elastometry and Minilaparoscopic Guided Liver Biopsy for the Diagnosis of Compensated Liver Cirrhosis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cirrhosis
- Sponsor
- University Hospital Erlangen
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Prospective Evaluation of Acoustic Radiation Force Impulse (ARFI) Elastography and High-Frequency B-Mode Ultrasound in Compensated Patients for the Diagnosis of Liver Fibrosis/Cirrhosis in Comparison to Mini-Laparoscopic Biopsy
- Last Updated
- 10 years ago
Overview
Brief Summary
Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.
Detailed Description
Up to now the gold standard for the diagnosis of liver cirrhosis is to perform liver biopsy. This invasive methode is not undisputed. Therefore there is constant effort to improve, develop and apply better diagnostic tools. This study is designed to evaluate the in our eyes now a days most promising examinations: (1) high frequency ultrasound, (2) elastometry and (3) minilaparoscopy. Patients for whom the clinical decision to perform mini laparoscopic guided liver biopsy was taken should be recruited. Successive at three time points the examiner has to decide for or against cirrhosis: (1) after conventional and high frequency ultrasound (2) after elastometry and (3) after laparoscopy.
Investigators
Prof. Dr. D. Strobel
Prof. Dr.
University Hospital Erlangen
Eligibility Criteria
Inclusion Criteria
- •clinical decision to perform minilaparoscopic guided liver biopsy for the staging of liver disease including the assessment of the degree of fibrosis.
Exclusion Criteria
- •decompensated liver disease
- •esophageal varices
- •other collateral circulations
- •obstructive cholestasis
- •severe heart insufficiency (NYHA III-IV)
Outcomes
Primary Outcomes
Prospective Evaluation of Acoustic Radiation Force Impulse (ARFI) Elastography and High-Frequency B-Mode Ultrasound in Compensated Patients for the Diagnosis of Liver Fibrosis/Cirrhosis in Comparison to Mini-Laparoscopic Biopsy
Time Frame: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours
Histology is obtained at minilaparoscopy. For an Ishak fibrosis stage of 5/6 or a clearly nodular liver surface at minilaparoscopy cirrhosis is confirmed.
Secondary Outcomes
- Can the non invasive tests be combined resulting in a better accuracy for the prediction of liver cirrhosis/fibrosis?(blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours)