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

• Conditions: Cirrhosis

• Registration Number: NCT01807013
• Lead Sponsor: University Hospital Erlangen

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Primary Completion: 2014-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitätsklinikum Erlangen Nürnberg; 🇩🇪 Erlangen, Bayern, Germany