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NCT Number: NCT07537569

Preoperative Oncogeriatric Assessment in Patients Undergoing 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

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Key information

Conditions

Hepatic Malignancies Comprehensive Geriatric Assessment Hepatectomy

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location contact

Chiara Schipa, MD

CONTACT

[email protected]

+39 0630154386

Chiara Schipa, MD

SUB_INVESTIGATOR

Felice Giuliante, MD

PRINCIPAL_INVESTIGATOR

Flaminio Sessa, MD

SUB_INVESTIGATOR

Francesco Ardito, MD, PhD

SUB_INVESTIGATOR

Francesco Razionale, MD, PhD

SUB_INVESTIGATOR

Laura Levantesi, MD

SUB_INVESTIGATOR

Maria Vellone, MD, PhD

SUB_INVESTIGATOR

Paola Aceto, MD, PhD

SUB_INVESTIGATOR

Tiziana Bove, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comprehensive geriatric assessment (CGA)

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Hospital readmission

    Time frame: From discharge date to 30 days after surgery

    30-day readmission

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Schipa, MD

CONTACT

[email protected]

+39 0630154386

Simone Vani, Bsc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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