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

January 20, 2016 updated by: Prof. Dr. D. Strobel, University Hospital Erlangen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen Nürnberg
        • Contact:
        • Principal Investigator:
          • Lukas Pfeifer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with suspected chronic liver disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

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
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.
blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Can the non invasive tests be combined resulting in a better accuracy for the prediction of liver cirrhosis/fibrosis?
Time Frame: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours
blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours

Other Outcome Measures

Outcome Measure
Time Frame
What liver related complications develop and by which test are they best predicted?
Time Frame: Follow up patients for 3/5 years
Follow up patients for 3/5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Erlangen

Investigators

  • Study Director: Deike Stobel, Prof. Dr., Universitätsklinikum Erlangen-Nürnberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LapSon

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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