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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01807013
• Other study ID #: LapSon
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2012
• Last updated: January 20, 2016
• Start date: February 2011
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: University Hospital Erlangen
• Contact: Deike Strobel, Prof. Dr.
• Phone: 09131 - 8535261
• Email: deike.strobel[@]uk-erlangen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen Nürnberg	Erlangen	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	What liver related complications develop and by which test are they best predicted?		Follow up patients for 3/5 years	No
Primary	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	No
Secondary	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	No