Evaluating Ultrasound, Elastometry, Minilaparoscopy and Histology for the Diagnosis of Compensated Liver Cirrhosis.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Study to Evaluate the Diagnostic Value of B-mode Ultrasound, Elastometry and Minilaparoscopic Guided Liver Biopsy for the Diagnosis of Compensated Liver Cirrhosis.

Conditions
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Cirrhosis

Intervention / Treatment
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* Procedure: ultrasound, liver elastometry, minilaparoscopy


Participation Criteria
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Eligibility Criteria
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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: ascites decompensated liver disease esophageal varices other collateral circulations obstructive cholestasis severe heart insufficiency (NYHA III-IV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ultrasound, liver elastometry, minilaparoscopy|conventional high-end ultrasound technique, small access laparoscopy with fine laparoscopes Acoustic radiation force impulse (ARFI): ARFI technology uses short-duration acoustic radiation forces (approximately 100 microseconds) to generate a localized tissue displacement which results in a lateral shear-wave propagation. ARFI shear wave velocity (SWV) measured in m/sec tracked with ultrasonic correlation-based methods is proportional to the square root of tissue elasticity.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Histology is obtained at minilaparoscopy. For an Ishak fibrosis stage of 5/6 or a clearly nodular liver surface at minilaparoscopy cirrhosis is confirmed. | blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, liver, elastometry, ultrasound, laparoscopy, diagnosis