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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03178409
Other study ID # cHCC-MFCCC
Secondary ID
Status Completed
Phase N/A
First received June 4, 2017
Last updated June 5, 2017
Start date January 1, 2004
Est. completion date May 15, 2017

Study information

Verified date June 2017
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 15, 2017
Est. primary completion date December 31, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Hepatectomy
Removal of a part of the liver

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Milan

Outcome

Type Measure Description Time frame Safety issue
Primary Survival analysis 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
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