Transient Elastography in Hepatectomy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Value of Transient Elastography in Predicting Postoperative Liver Failure in Patients Undergoing Liver Resection for Hepatocellular Carcinoma.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01441453
• Other study ID #: FibroBoResect-01
• Status: Not yet recruiting
• Phase: N/A
• First received: September 24, 2011
• Last updated: September 26, 2011

Study information

• Verified date: September 2011
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Matteo Cescon, MD, PhD
• Phone: +39-51-6364810
• Email: matteo.cescon[@]unibo.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients already scheduled to undergo liver resection fo hepatocellular carcinoma

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Surgery

Intervention

Procedure:
• FibroScan (Transient Elastography measurement)
Preoperative evaluation of liver stiffness through FibroScan

Locations

Country	Name	City	State
Italy	General Surgery and Organ Transplantation Unit, Policlinico Sant'Orsola-Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of postoperative hospital stay, an expected average of 4 weeks	No