Transient Elastography in Hepatectomy for Hepatocellular Carcinoma
- Conditions
- SurgeryHepatocellular Carcinoma
- Interventions
- Procedure: FibroScan (Transient Elastography measurement)
- Registration Number
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Patients already scheduled to undergo liver resection fo hepatocellular carcinoma
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Preoperative FibroScan FibroScan (Transient Elastography measurement) -
- Primary Outcome Measures
Name Time Method Cut-off value of liver stiffness measured in kilopascal (kPa) able to predict the occurrence of postoperative liver failure. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
General Surgery and Organ Transplantation Unit, Policlinico Sant'Orsola-Malpighi
🇮🇹Bologna, Italy