NCT02454686

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

May 19, 2015

Last Update Submit

May 26, 2015

Conditions

Liver Neoplasms

Keywords

Complications after hepatectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A prospective cohort of patients scheduled for hepatectomy.

You may qualify if:

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

You may not qualify if:

  • Refute to get the Fibroscan
  • Loss of data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28743491DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Guido Torzilli, MD, PhD

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 27, 2015

Study Start

February 1, 2012

Primary Completion

October 1, 2014

Study Completion

May 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05