Resection for Multiple Hepatocellular Carcinomas (HCC) | NCT01387061

Studies
Resection for Multiple Hepatocellular Carcinomas (HCC)

NCT01387061

Sponsor

University of Milan

Status

Completed

Last Update Posted

Sep 20, 2011Estimated

Enrollment

87Actual

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma
Multiple Tumors
Cirrhosis

Interventions

hepatic resection

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 29, 2011

First Submission Date that Met QC Criteria

Jul 1, 2011

First Posted Date

Jul 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2011

Last Update Posted Date

Sep 20, 2011Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hepatic resection	Experimental		Procedure: hepatic resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hepatic resection	Procedure	surgical resection of the liver for multiple HCC	hepatic resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Disease-free survival	The secondary endpoint was the disease-free survival.	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with multiple HCC without macrovascular invasion on liver cirrhosis

Exclusion Criteria:

macrovascular invasion;
normal liver;
distant or lymphnodes metastasis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guido Torzilli, MD, PhD	University of Milan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Milan IRCCS Istituto Clinico Humanitas		Rozzano, Milan	MI	20089	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D005355	Fibrosis

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided