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Transient Elastography in Hepatectomy for Hepatocellular Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Matteo Cescon, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441453
First Posted: September 27, 2011
Last Update Posted: September 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matteo Cescon, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
  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: Intervention Model: Single Group Assignment
Masking: None (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 Matteo Cescon, 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients already scheduled to undergo liver resection fo hepatocellular carcinoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 24, 2011
First Posted: September 27, 2011
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by Matteo Cescon, 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