Multidisciplinary Management of HCC in Elderly Patients

Quality of Life Clinical Trial

Official title:

Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875417
• Other study ID #: HEP001
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: March 2019
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 31, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• HCC patient

• eligible for surgery

Exclusion Criteria:

• non eligible for surgery at first HCC diagnosis

Related Conditions & MeSH terms

• HCC
• Quality of Life

Intervention

Procedure:
• liver resection
resection of one or more HCC nodules within the liver
• Thermic ablation
ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves
• Transcatheter arterial chemoembolization
embolization of HCC nodule via drug-eluted microbeads.

Locations

Country	Name	City	State
Italy	Department of Surgery "Pietro Valdoni"	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	survival in months	follow up time 1-16 years
Primary	Disease free survival	survival without recurrences in months	follow up time 1-16 years
Secondary	Karnofsky performance scale	evaluation of performance status in dimensionless scale 0 - 100	follow up time 1-16 years
Secondary	Activity of Daily living	assess the ability to manage common routine activities evaluated in dimensionless scale 1-6	follow up time 1-16 years
Secondary	Instrumental Activity of Daily living	assess the ability to use common instruments evaluated in dimensionless scale 1-8	follow up time 1-16 years
Secondary	Blood Haemoglobin	evaluation of mean haemoglobin levels in g/dl	follow up time 1-16 years
Secondary	serum Albumin	evaluation of mean albumin levels in g/dl	follow up time 1-16 years
Secondary	Geriatric Depression Scale	evaluation of depression in patients in dimensionless scale 0 - 15	follow up time 1-16 years