Fibroscan Predicts Complications After Hepatectomy

Liver Neoplasms Clinical Trial

— Fibroscan  

Official title:

Role of Fibroscan in Predicting Complications After Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454686
• Other study ID #: Fibroscan
• Status: Completed
• Phase: N/A
• First received: May 19, 2015
• Last updated: May 26, 2015
• Start date: February 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Fibroscan in predicting complication after hepatectomy	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	90 days	No