Combined HCC-MFCCC

June 5, 2017 updated by: Prof. Guido Torzilli, University of Milan

Survival After Hepatectomy for Combined Hepatocellular Cholagiocarcinoma

Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The aim of this study was the analysis of the outcome comparing such tumor with classic hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The institutional prospectively maintained database was queried, and 20 patients with cHCC-MFCCC were identified. A 2:1 match was performed with 40 patients operated in the same period for HCC, and with 40 operated for MFCCC. Only T1 or T2 patients N0 M0 were considered. Primary endpoint was the overall survival (OS) and disease-free survival (DFS).

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by cHCC-MFCCC, or HCC or MFCCC.

Description

Inclusion Criteria:

  • positive histology for cHCC-MFCCC, HCC, and MFCCC
  • complete clinical, surgical, pathological and follow-up data.

Exclusion Criteria:

  • patients preoperatively treated with chemotherapy, radiofrequency ablation or trans-arterial therapies were excluded.
  • patients operated for recurrent disease and/or with non-radical surgery
  • patients with missing data were also excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cHCC-MFCCC
Patients affected by combined HCC-MFCCC
Procedure: Hepatectomy
Removal of a part of the liver
Other Names:
  • Liver resection
  • Liver surgery
HCC
Patients affected by classical HCC
Procedure: Hepatectomy
Removal of a part of the liver
Other Names:
  • Liver resection
  • Liver surgery
MFCCC
Patients affected by classical MFCCC
Procedure: Hepatectomy
Removal of a part of the liver
Other Names:
  • Liver resection
  • Liver surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival analysis
Time Frame: From 3 months after surgery up to 60 months after surgery
Analysis of overall and disease-free survival of patients resected for cHCC-MFCCC versus those resected for HCC versus those resected for MFCCC
From 3 months after surgery up to 60 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2004

Primary Completion (Actual)

December 31, 2014

Study Completion (Actual)

May 15, 2017

Study Registration Dates

First Submitted

June 4, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cHCC-MFCCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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