Resection for Multiple Hepatocellular Carcinomas (HCC)

Hepatocellular Carcinoma Clinical Trial

Official title:

Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387061
• Other study ID #: multipleHCC
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: September 18, 2011
• Start date: June 2001
• Est. completion date: June 2011

Study information

• Verified date: September 2011
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains controversial. The aim of this study was to investigate the outcome of a consecutive cohort of patients resected for multiple HCC, without macrovascular invasion, in order to identify clinically reliable parameters to select patients for surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with multiple HCC without macrovascular invasion on liver cirrhosis

Exclusion Criteria:

• macrovascular invasion;

• normal liver;

• distant or lymphnodes metastasis

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Multiple Tumors

Intervention

Procedure:
• hepatic resection
surgical resection of the liver for multiple HCC

Locations

Country	Name	City	State
Italy	University of Milan IRCCS Istituto Clinico Humanitas	Rozzano, Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival plus multivariate analysis	The primary endpoint of the study was the overall survival of patients resected for multiple HCC, and the univariate and multivariate analyses of prognostic factors for overall survival.	10 years	No
Secondary	Disease-free survival	The secondary endpoint was the disease-free survival.	10 years	No