NCT01387061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jun 2001

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

10 years

First QC Date

June 29, 2011

Last Update Submit

September 18, 2011

Conditions

Hepatocellular CarcinomaMultiple TumorsCirrhosis

Keywords

liver resectionhepatic resectionintraoperative ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Disease-free survival

    10 years

Study Arms (1)

hepatic resection

EXPERIMENTAL
Procedure: hepatic resection

Interventions

hepatic resectionPROCEDURE

surgical resection of the liver for multiple HCC

hepatic resection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with multiple HCC without macrovascular invasion on liver cirrhosis

You may not qualify if:

  • macrovascular invasion;
  • normal liver;
  • distant or lymphnodes metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Milan IRCCS Istituto Clinico Humanitas

Rozzano, Milan, MI, 20089, Italy

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularFibrosis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guido Torzilli, MD, PhD

    University of Milan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

June 29, 2011

First Posted

July 4, 2011

Study Start

June 1, 2001

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations

IT(1)