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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound, liver elastometry, minilaparoscopy | Procedure |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| What liver related complications develop and by which test are they best predicted? | Follow up patients for 3/5 years |
Inclusion Criteria:
Exclusion Criteria:
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patients with suspected chronic liver disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deike Strobel, Prof. Dr. | Contact | 09131 - 8535261 | deike.strobel@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Deike Stobel, Prof. Dr. | Universitätsklinikum Erlangen-Nürnberg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen Nürnberg | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| D055585 |
| Physical Phenomena |