Fibroscan Predicts Complications After Hepatectomy (Fibroscan)

May 26, 2015 updated by: Prof. Guido Torzilli, University of Milan

Role of Fibroscan in Predicting Complications After Hepatectomy

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

240

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A prospective cohort of patients scheduled for hepatectomy.

Description

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 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
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	90 days

Collaborators and Investigators

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

Sponsor

University of Milan

Investigators

Study Director: Guido Torzilli, MD, PhD, Humanitas Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Donadon M, Fontana A, Palmisano A, Vigano L, Procopio F, Cimino M, Del Fabbro D, Torzilli G. Individualized risk estimation for postoperative morbidity after hepatectomy: the Humanitas score. HPB (Oxford). 2017 Oct;19(10):910-918. doi: 10.1016/j.hpb.2017.06.009. Epub 2017 Jul 22.

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, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)