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Combined HCC-MFCCC

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ClinicalTrials.gov Identifier: NCT03178409
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan

Brief Summary:
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).

Condition or disease Intervention/treatment
Liver Carcinoma Hepatocellular Carcinoma Cholangiocarcinoma Surgery Procedure: Hepatectomy

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).

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Survival After Hepatectomy for Combined Hepatocellular Cholagiocarcinoma
Actual Study Start Date : January 1, 2004
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by cHCC-MFCCC, or HCC or MFCCC.
Criteria

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
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Responsible Party: Prof. Guido Torzilli, Director of the Department of Hepatobiliary and General Surgery, University of Milan
ClinicalTrials.gov Identifier: NCT03178409    
Other Study ID Numbers: cHCC-MFCCC
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics