NCT03178409

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

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

January 1, 2004

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

11 years

First QC Date

June 4, 2017

Last Update Submit

June 5, 2017

Conditions

Liver CarcinomaHepatocellular CarcinomaCholangiocarcinomaSurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

cHCC-MFCCC

Patients affected by combined HCC-MFCCC

Procedure: Hepatectomy

HCC

Patients affected by classical HCC

Procedure: Hepatectomy

MFCCC

Patients affected by classical MFCCC

Procedure: Hepatectomy

Interventions

HepatectomyPROCEDURE

Removal of a part of the liver

Also known as: Liver resection, Liver surgery
HCCMFCCCcHCC-MFCCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, HepatocellularCholangiocarcinoma

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Hepatobiliary and General Surgery

Study Record Dates

First Submitted

June 4, 2017

First Posted

June 6, 2017

Study Start

January 1, 2004

Primary Completion

December 31, 2014

Study Completion

May 15, 2017

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share