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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-08-31

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.

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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.

Conditions

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Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No