Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01664780
First received: August 10, 2012
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI) imaging to assess liver fibrosis in patients after orthotopic liver transplantation.

Material and methods: We prospectively assess the performance of ARFI imaging in planned 100 patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the results with clinical data and B-mode criteria.

ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in patients after orthotopic liver transplantation. Therefore we want to establish standard values in this population.


Condition Intervention
Liver Transplantation
Device: ARFI imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients after liver transplantation Device: ARFI imaging

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients after orthotopic liver transplantation

Criteria

Inclusion Criteria:

  • Patients after orthotopic liver transplantation.

Exclusion Criteria:

  • Patients without status after orthotopic liver transplantation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664780

Locations
Germany
University Hospital of Erlangen, Dep. of Medicine 1 Recruiting
Erlangen, Germany, 91054
Contact: Dane Wildner, MD    0049 9131 8535250    dane.wildner@uk-erlangen.de   
Contact: Steffen Zopf, MD    0049 9131 8535250    steffen.Zopf@uk-erlangen.de   
Sub-Investigator: Deike Strobel, MD         
Principal Investigator: Dane Wildner, MD         
Principal Investigator: Steffen Zopf, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Dane Wildner, MD Dep. of Medicine 1, University of Erlangen-Nuremberg
  More Information

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01664780     History of Changes
Other Study ID Numbers: ARFI-UK Erlangen
Study First Received: August 10, 2012
Last Updated: August 13, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:
standard
values
share
wave velocity
in ARFI imaging

ClinicalTrials.gov processed this record on August 20, 2014