Preoperative Oncogeriatric Assessment in Patients Undergoing Hepatectomy

April 16, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Impact of Preoperative Oncogeriatric Assessment in Elderly Patients Undergoing Surgery for Hepatectomy

This study aims to bridge the gap between geriatric medicine and surgical oncology. The findings will provide valuable insights into optimizing perioperative care for older adults, enhancing surgical safety, and improving long-term recovery trajectories, thereby supporting a more patient-centered, multidisciplinary approach in the management of elderly patients undergoing hepatectomy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Principal Investigator:
          • Felice Giuliante, MD
        • Sub-Investigator:
          • Francesco Ardito, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Chiara Schipa, MD
        • Sub-Investigator:
          • Tiziana Bove, MD
        • Sub-Investigator:
          • Paola Aceto, MD, PhD
        • Sub-Investigator:
          • Maria Vellone, MD, PhD
        • Sub-Investigator:
          • Laura Levantesi, MD
        • Sub-Investigator:
          • Flaminio Sessa, MD
        • Sub-Investigator:
          • Francesco Razionale, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged ≥ 70 years
  • Diagnosed hepatic malignancies requiring hepatectomy
  • Eligible for curative surgery as determined by multidisciplinary team
  • Ability to provide informed consent.

Exclusion Criteria:

  • Ineligibility for surgery due to advanced disease or severe comorbidities
  • Severe cognitive impairment (MMSE score < 18)
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive Geriatric Assessment (CGA) Group

Subjects undergo Comprehensive Geriatric Assessment (CGA) assessing frailty, functional status, cognition, comorbidities, nutritional and mental health status using validated tools (Fried Criteria, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Charlson Comorbidity Index, Mini Nutritional Assessment, Geriatric Depression Scale).

Subjects receive targeted preoperative interventions (nutritional support, prehabilitation, medical optimization, psychosocial support).
Other: Comprehensive Geriatric Assessment (CGA)
The Comprehensive Geriatric Assessment (CGA) is conducted using a structured approach integrating validated tools into routine preoperative evaluation: frailty assessed by Fried Frailty Criteria; functional status by Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL); cognitive function by Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA); comorbidity burden by Charlson Comorbidity Index; nutritional status by Mini Nutritional Assessment (MNA); psychological status by Geriatric Depression Scale (GDS). Based on CGA findings, participants may receive individualized preoperative interventions including nutritional optimization, physical prehabilitation, medical optimization, and psychosocial or educational support.
No Intervention: Standard of Care Group
Subjects receive standard preoperative care including anesthesia, surgical procedures, and postoperative management according to institutional protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Major Postoperative Complications (Clavien-Dindo Grade ≥ III)
Time Frame: From surgery to 30 days after surgery
Number of participants experiencing major postoperative complications, defined as grade III or higher according to the Clavien-Dindo Classification of Surgical Complications. The Clavien-Dindo classification ranges from grade I (minor complications) to grade V (death), with higher grades indicating more severe complications, assessed within 30 days after surgery.
From surgery to 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From enrollment to 12 months after surgery
Overall survival (OS), defined as the time from enrollment to death from any cause, assessed at 12 months
From enrollment to 12 months after surgery
Quality of Life Assessed at 3 and 6 Months
Time Frame: From enrollment to 3 and 6 months after surgery
Change from baseline in quality of life scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The questionnaire includes multiple domains scored from 0 to 100. For functional scales and global health status, higher scores indicate better quality of life; for symptom scales, higher scores indicate worse symptoms
From enrollment to 3 and 6 months after surgery
Lenght of hospital stay
Time Frame: From date of surgery to hospital discharge (up to 90 days postoperatively)
Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge
From date of surgery to hospital discharge (up to 90 days postoperatively)
Hospital readmission
Time Frame: From discharge date to 30 days after surgery
30-day readmission
From discharge date to 30 days after surgery
Functional Status Assessed by Activities of Daily Living (ADL)
Time Frame: From baseline (preoperative) to 3 and 6 months after surgery
Functional status measured using the Activities of Daily Living (ADL) scale. ADL scores range from 0 to 6, with higher scores indicating greater independence. Change from baseline will be assessed at 3 and 6 months after surgery
From baseline (preoperative) to 3 and 6 months after surgery
Functional Status Assessed by Instrumental Activities of Daily Living (IADL)
Time Frame: From baseline (preoperative) to 3 and 6 months after surgery
Functional status measured using the Instrumental Activities of Daily Living (IADL) scale. IADL scores range from 0 to 8, with higher scores indicating greater independence. Change from baseline will be assessed at 3 and 6 months after surgery
From baseline (preoperative) to 3 and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Felice Giuliante, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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