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Fibroscan Predicts Complications After Hepatectomy (Fibroscan)

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ClinicalTrials.gov Identifier: NCT02454686
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan

Brief Summary:
Most of the postoperative complications that may occur after hepatectomy are related to the underlying liver background, and the common preoperative tests do not completely predict such complications. Transient elastography by Fibroscan is used to calculate the stiffness and the steatosis of the liver, and it may be also used to predict postoperative complications after hepatectomy

Condition or disease
Liver Neoplasms

Detailed Description:
A prospective cohort study on consecutive patients scheduled for hepatectomy was planned. Fibroscan was performed during the preoperative workup. Accuracy of the liver stiffness and steatosis measured by Fibroscan in predicting the presence of cirrhosis, of steatosis, and the development of postoperative complications was assessed by ROC curve, and multivariate analysis.

Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Fibroscan in Predicting Complications After Hepatectomy
Study Start Date : February 2012
Primary Completion Date : October 2014
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Accuracy of Fibroscan in predicting complication after hepatectomy [ Time Frame: 90 days ]
    Calculation of the accuracy of the liver stiffness and steatosis measured with the Fibroscan in predicting complications after hepatectomy. The values of the stiffness and steatosis will be correlated with the number of complications

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A prospective cohort of patients scheduled for hepatectomy.

Inclusion Criteria:

  • Patients with primary and secondary tumors scheduled for hepatectomy at our Unit
  • Written consent to get the Fibroscan during the preoperative workup

Exclusion Criteria:

  • Refute to get the Fibroscan
  • Loss of data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454686

Sponsors and Collaborators
University of Milan
Study Director: Guido Torzilli, MD, PhD Humanitas Research Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan
ClinicalTrials.gov Identifier: NCT02454686     History of Changes
Other Study ID Numbers: Fibroscan
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Prof. Guido Torzilli, University of Milan:
Complications after hepatectomy

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases