NCT01441453

Brief Summary

The purpose of this study is to determine whether liver transient elastography performed before the surgical procedure is able to predict liver failure in patients undergoing hepatectomy for hepatocellular carcinoma.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

First QC Date

September 24, 2011

Last Update Submit

September 26, 2011

Conditions

SurgeryHepatocellular Carcinoma

Keywords

Hepatocellular carcinomaCirrhosisLiver resectionFibroScan

Outcome Measures

Primary Outcomes (1)

  • Cut-off value of liver stiffness measured in kilopascal (kPa) able to predict the occurrence of postoperative liver failure.

    Definition of the cut-off value in kPa able to predict postoperative liver failure, i.e. the presence of at least one of the following variables: ascites causing a delay in the removal of surgical drainages and/or requiring paracentesis; increase of bilirubin levels \>3 mg/dL; alteration of coagulation factors requiring plasma infusion with an INR above 1.50 (with serum bilirubin levels \<12mg/dL); renal impairment, defined as blood urea nitrogen \>2.00 g/L and/or increase of serum creatinine \>2.00 mg/dL requiring only loop diuretics, dopamine/terlipressin, or dialysis.

    Participants will be followed for the duration of postoperative hospital stay, an expected average of 4 weeks

Study Arms (1)

Preoperative FibroScan

OTHER
Procedure: FibroScan (Transient Elastography measurement)

Interventions

FibroScan (Transient Elastography measurement)PROCEDURE

Preoperative evaluation of liver stiffness through FibroScan

Preoperative FibroScan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients already scheduled to undergo liver resection fo hepatocellular carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Surgery and Organ Transplantation Unit, Policlinico Sant'Orsola-Malpighi

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularFibrosis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matteo Cescon, MD, PhD

    Policlinico Sant'Orsola-Malpighi, University of Bologna, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Cescon, MD, PhD

CONTACT

+39-51-6364810matteo.cescon@unibo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assistant Professor of Surgery

Study Record Dates

First Submitted

September 24, 2011

First Posted

September 27, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

IT(1)