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AzTrials

Hepatic MalignanciesNCT07537569

Preoperative Oncogeriatric Assessment in Patients Undergoing Hepatectomy

A study testing Comprehensive Geriatric Assessment (CGA) in people with Hepatic Malignancies and Comprehensive Geriatric Assessment, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Comprehensive Geriatric Assessment (CGA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
1 siteItaly
Study dates
9 Apr 2026to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chiara Schipa, MD contact

+39 0630154386

chiara.schipa@policlinicogemelli.it

Simone Vani, Bsc contact

simone.vani@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM, 00168

    Chiara Schipa, MD, +39 0630154386, chiara.schipa@policlinicogemelli.it

    Felice Giuliante, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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

Being tested
Comprehensive Geriatric Assessment (CGA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07537569
Study groupRoleWhat they receive
Comprehensive Geriatric Assessment (CGA) GroupExperimentalSubjects 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).
Receives: Other: Comprehensive Geriatric Assessment (CGA)
Standard of Care GroupNo interventionSubjects receive standard preoperative care including anesthesia, surgical procedures, and postoperative management according to institutional protocols

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Major Postoperative Complications (Clavien-Dindo Grade ≥ III)

    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.

    Measured: From surgery to 30 days after surgery

Secondary outcomes (6)

  1. Overall Survival

    Overall survival (OS), defined as the time from enrollment to death from any cause, assessed at 12 months

    Measured: From enrollment to 12 months after surgery

  2. Quality of Life Assessed at 3 and 6 Months

    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

    Measured: From enrollment to 3 and 6 months after surgery

  3. Lenght of hospital stay

    Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge

    Measured: From date of surgery to hospital discharge (up to 90 days postoperatively)

  4. Hospital readmission

    30-day readmission

    Measured: From discharge date to 30 days after surgery

  5. Functional Status Assessed by Activities of Daily Living (ADL)

    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

    Measured: From baseline (preoperative) to 3 and 6 months after surgery

  6. Functional Status Assessed by Instrumental Activities of Daily Living (IADL)

    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

    Measured: From baseline (preoperative) to 3 and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study start9 Apr 2026
  3. Primary completionApr 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
242 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07537569
Sponsor's protocol ID
8205
Status last verified
Sep 2026
First submitted
1 Apr 2026
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schipa C, Luca E, Ripa M, Sollazzi L, Aceto P. Preoperative evaluation of the elderly patient. Saudi J Anaesth. 2023 Oct-Dec;17(4):482-490. doi: 10.4103/sja.sja_613_23. Epub 2023 Aug 18.

    PubMed 37779566

  • Steenblock J, Braisch U, Brefka S, Thomas C, Eschweiler GW, Rapp M, Metz B, Maurer C, von Arnim CAF, Herrmann ML, Wagner S, Denkinger M, Dallmeier D. Frailty index and its association with the onset of postoperative delirium in older adults undergoing elective surgery. BMC Geriatr. 2023 Feb 11;23(1):90. doi: 10.1186/s12877-022-03663-7.

    PubMed 36774453

  • Kumar C, Salzman B, Colburn JL. Preoperative Assessment in Older Adults: A Comprehensive Approach. Am Fam Physician. 2018 Aug 15;98(4):214-220.

    PubMed 30215973

  • Chen L, Zong W, Luo M, Yu H. The impact of comprehensive geriatric assessment on postoperative outcomes in elderly surgery: A systematic review and meta-analysis. PLoS One. 2024 Aug 28;19(8):e0306308. doi: 10.1371/journal.pone.0306308. eCollection 2024.

    PubMed 39197016

  • Hoffmann TC, Del Mar C. Patients' expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015 Feb;175(2):274-86. doi: 10.1001/jamainternmed.2014.6016.

    PubMed 25531451

  • Neuman MD, Silber JH, Magaziner JS, Passarella MA, Mehta S, Werner RM. Survival and functional outcomes after hip fracture among nursing home residents. JAMA Intern Med. 2014 Aug;174(8):1273-80. doi: 10.1001/jamainternmed.2014.2362.

    PubMed 25055155

  • Oresanya LB, Lyons WL, Finlayson E. Preoperative assessment of the older patient: a narrative review. JAMA. 2014 May;311(20):2110-20. doi: 10.1001/jama.2014.4573.

    PubMed 24867014

  • Chow WB, Rosenthal RA, Merkow RP, Ko CY, Esnaola NF; American College of Surgeons National Surgical Quality Improvement Program; American Geriatrics Society. Optimal preoperative assessment of the geriatric surgical patient: a best practices guideline from the American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society. J Am Coll Surg. 2012 Oct;215(4):453-66. doi: 10.1016/j.jamcollsurg.2012.06.017. Epub 2012 Aug 21. No abstract available.

    PubMed 22917646

  • Partridge JS, Harari D, Martin FC, Dhesi JK. The impact of pre-operative comprehensive geriatric assessment on postoperative outcomes in older patients undergoing scheduled surgery: a systematic review. Anaesthesia. 2014 Jan;69 Suppl 1:8-16. doi: 10.1111/anae.12494.

    PubMed 24303856

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive Geriatric Assessment (CGA) in people with Hepatic Malignancies and Comprehensive Geriatric Assessment, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chiara Schipa, MD (+39 0630154386, chiara.schipa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Major Postoperative Complications (Clavien-Dindo Grade ≥ III) (time frame: From surgery to 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07537569, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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