Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Matteo Cescon, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Italy: Ethics Committee

Study ID:

FibroBoResect-01

NCT ID:

NCT01441453

Start Date:

Completion Date:

Related Keywords:

• Surgery
• Hepatocellular Carcinoma
• Hepatocellular carcinoma
• Cirrhosis
• Liver resection
• FibroScan
• Carcinoma
• Carcinoma, Hepatocellular

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