Multidisciplinary Management of HCC in Elderly Patients

NCT ID: NCT03875417

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-10-31

Brief Summary

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Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Detailed Description

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Introduction- Hepatocellular carcinoma (HCC) is the most common primary liver malignancy. It usually develops in cirrhotic liver with high recurrence rates. More than 2/3 of patients are elderly, often excluded from surgery and follow-up protocols. Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Materials and methods- 126 patients, aged between 65 and 90 years, submitted to liver resection for HCC were enrolled. They were divided into three classes. Class 1 included patients submitted to major resections, Class 2 to minor resections and Class 3 to minor resections associated with thermoablation. All of them were clinically and radiologically followed up. Patients who developed recurrences (Group A) were referred to further treatments (surgery, interventional radiology or pharmacological therapy). Mortality, disease-free survival (DFS), overall survival (OS) and quality of life (QoL) were evaluated and compared with non-recurrent patients (Group B).

Used interventional radiology means were Radiofrequency ablation (RF), microwaves ablation (MWA) or transcatheter arterial chemoembolization (TACE).

Conditions

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HCC Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

Patients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means.

liver resection

Intervention Type PROCEDURE

resection of one or more HCC nodules within the liver

Thermic ablation

Intervention Type PROCEDURE

ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves

Transcatheter arterial chemoembolization

Intervention Type PROCEDURE

embolization of HCC nodule via drug-eluted microbeads.

Group B

Patients who did not develop recurrences after surgery.

liver resection

Intervention Type PROCEDURE

resection of one or more HCC nodules within the liver

Interventions

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liver resection

resection of one or more HCC nodules within the liver

Intervention Type PROCEDURE

Thermic ablation

ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves

Intervention Type PROCEDURE

Transcatheter arterial chemoembolization

embolization of HCC nodule via drug-eluted microbeads.

Intervention Type PROCEDURE

Other Intervention Names

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RF (radiofrequency ablation) / MWA (microwaves ablation)

Eligibility Criteria

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Inclusion Criteria

* HCC patient
* eligible for surgery

Exclusion Criteria

* non eligible for surgery at first HCC diagnosis
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Policlinico Umberto I

OTHER

Sponsor Role lead

Responsible Party

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Professor Stefania Brozzetti

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefania Brozzetti, Professor

Role: PRINCIPAL_INVESTIGATOR

Policlinico Umberto I - Sapienza università di Roma

Locations

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Department of Surgery "Pietro Valdoni"

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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HEP001

Identifier Type: -

Identifier Source: org_study_id

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