Multidisciplinary Management of HCC in Elderly Patients

Completed

• Conditions: Quality of Life; HCC
• Interventions: Procedure: liver resection; Procedure: Thermic ablation; Procedure: Transcatheter arterial chemoembolization

• Registration Number: NCT03875417
• Lead Sponsor: Azienda Policlinico Umberto I

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-10-31
• Status Verified: 2019-03
• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-12
• Last Update Submitted: 2019-03-12
• Study First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• HCC patient
• eligible for surgery

Exclusion Criteria

• non eligible for surgery at first HCC diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Transcatheter arterial chemoembolization	Patients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means.
Group B	liver resection	Patients who did not develop recurrences after surgery.
Group A	liver resection	Patients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means.
Group A	Thermic ablation	Patients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means.

Primary Outcome Measures

Name	Time	Method
Overall survival	follow up time 1-16 years	survival in months
Disease free survival	follow up time 1-16 years	survival without recurrences in months

Secondary Outcome Measures

Name	Time	Method
Blood Haemoglobin	follow up time 1-16 years	evaluation of mean haemoglobin levels in g/dl
Activity of Daily living	follow up time 1-16 years	assess the ability to manage common routine activities evaluated in dimensionless scale 1-6
Karnofsky performance scale	follow up time 1-16 years	evaluation of performance status in dimensionless scale 0 - 100
Geriatric Depression Scale	follow up time 1-16 years	evaluation of depression in patients in dimensionless scale 0 - 15
Instrumental Activity of Daily living	follow up time 1-16 years	assess the ability to use common instruments evaluated in dimensionless scale 1-8
serum Albumin	follow up time 1-16 years	evaluation of mean albumin levels in g/dl

Trial Locations

Locations (1)

Department of Surgery "Pietro Valdoni"; 🇮🇹 Roma, Italy