Back to resultsTransient Elastography in Hepatectomy for Hepatocellular Carcinoma
Primary Purpose
Surgery, Hepatocellular Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
FibroScan (Transient Elastography measurement)
Sponsored by
About this trial
This is an interventional diagnostic trial for Surgery focused on measuring Hepatocellular carcinoma, Cirrhosis, Liver resection, FibroScan
Eligibility Criteria
Inclusion Criteria:
- Patients already scheduled to undergo liver resection fo hepatocellular carcinoma
Sites / Locations
- General Surgery and Organ Transplantation Unit, Policlinico Sant'Orsola-Malpighi
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Preoperative FibroScan
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01441453
First Posted
September 24, 2011
Last Updated
September 26, 2011
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT01441453
Brief Title
Transient Elastography in Hepatectomy for Hepatocellular Carcinoma
Official Title
Value of Transient Elastography in Predicting Postoperative Liver Failure in Patients Undergoing Liver Resection for Hepatocellular Carcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Cirrhosis, Liver resection, FibroScan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative FibroScan
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
FibroScan (Transient Elastography measurement)
Intervention Description
Preoperative evaluation of liver stiffness through FibroScan
Primary Outcome Measure Information:
Title
Cut-off value of liver stiffness measured in kilopascal (kPa) able to predict the occurrence of postoperative liver failure.
Description
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.
Time Frame
Participants will be followed for the duration of postoperative hospital stay, an expected average of 4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients already scheduled to undergo liver resection fo hepatocellular carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matteo Cescon, MD, PhD
Phone
+39-51-6364810
Email
matteo.cescon@unibo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Cescon, MD, PhD
Organizational Affiliation
Policlinico Sant'Orsola-Malpighi, University of Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Surgery and Organ Transplantation Unit, Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Cescon, MD, PhD
Email
matteo.cescon@unibo.it
First Name & Middle Initial & Last Name & Degree
Matteo Cescon, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Transient Elastography in Hepatectomy for Hepatocellular Carcinoma
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