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Transient Elastography in Hepatectomy for Hepatocellular Carcinoma

This study is not yet open for participant recruitment.
Verified September 2011 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Information provided by (Responsible Party):
Matteo Cescon, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01441453
First received: September 24, 2011
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Surgery
Hepatocellular Carcinoma
 Procedure: FibroScan (Transient Elastography measurement)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Value of Transient Elastography in Predicting Postoperative Liver Failure in Patients Undergoing Liver Resection for Hepatocellular Carcinoma.

Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • Cut-off value of liver stiffness measured in kilopascal (kPa) able to predict the occurrence of postoperative liver failure. [ Time Frame: Participants will be followed for the duration of postoperative hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Arms Assigned Interventions
Preoperative FibroScan Procedure: FibroScan (Transient Elastography measurement)
Preoperative evaluation of liver stiffness through FibroScan

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients already scheduled to undergo liver resection fo hepatocellular carcinoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441453

Contacts
Contact: Matteo Cescon, MD, PhD +39-51-6364810 matteo.cescon@unibo.it

Locations
Italy
General Surgery and Organ Transplantation Unit, Policlinico Sant'Orsola-Malpighi Not yet recruiting
Bologna, Italy, 40138
Contact: Matteo Cescon, MD, PhD         matteo.cescon@unibo.it    
Principal Investigator: Matteo Cescon, MD, PhD            
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
Principal Investigator: Matteo Cescon, MD, PhD Policlinico Sant'Orsola-Malpighi, University of Bologna, Italy
  More Information

No publications provided

Responsible Party: Matteo Cescon, MD, PhD, Assistant Professor of Surgery, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01441453     History of Changes
Other Study ID Numbers: FibroBoResect-01
Study First Received: September 24, 2011
Last Updated: September 26, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Hepatocellular carcinoma
Cirrhosis
Liver resection
FibroScan

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 23, 2013