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AzTrials

Hepatobiliary CancerPhase 2/3HPB70+NCT06999512

Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer

A Phase 2/3 study testing Comprehensive Geriatric Assessment in people with Hepatobiliary Cancer and Pancreatic Cancer, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The worldwide incidence of hepatobiliary and pancreatic (HPB) cancers is dramatically increasing especially for pancreatic cancer. Increasing age is associated with increased cancer risk. In North America and Europe, most people who are diagnosed with cancer every year are aged 65 years or older. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Hepatobiliary Cancer, Pancreatic Cancer
What is being tested?
Comprehensive Geriatric Assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
526 participants
Where
12 sitesFrance
Study dates
Sep 2025to Dec 2030
Phase
Phase 2/3
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 ≥ 70 years, with histologically proven or clinical diagnosis of HPB cancer among the following:
  • hepatocellular carcinoma
  • intra-hepatic and peri-hilar cholangiocarcinoma
  • gallbladder cancer
  • peri-ampullary malignant tumors
  • pancreatic adenocarcinoma
Show all 10Show fewer
  • colorectal liver metastases
  • Needing one of the following procedures:
  • Pancreaticoduodenectomy
  • Major Hepatectomy (≥ 3 hepatic segments)

Who cannot join

  • Patients who have no access to the French health system.
  • Patient unable to sign informed consent.
  • Patients included in a double-blind randomized trial
  • Patients legally protected

Trial locations and contacts

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

Gabriella PITTAU, PhD contact

+33145596501 ext. +33

gabriella.pittau@aphp.fr

12 sites in 1 country

France12 sites

  • CHU Estaing

    Clermont-Ferrand, 63000

    Joan GAGNIERE

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

    Solafah ABDALLA

  • Chru Lille - Hopital Huriez

    Lille, 59000

    Stéphanie TRUANT

  • Hôpital Croix Rousse, HCL

    Lyon, 69000

    Jean-Yves MABRUT

  • Hôpital Edouard Herriot, HCL

    Lyon, 69000

    Julie Perinel

  • Hôpital La Timone

    Marseille, 13000

    Sophie CHOPINET

  • Hôpital Cochin

    Paris, 75014

    Ugo MARCHESE

  • Institut Mutualiste Montsouris

    Paris, 75014

    Ecoline TRIBILLON

  • CHU ROUEN - Site Charles Nicolle

    Rouen, 76000

    Lilian SCHWARZ

  • Hôpital Rangueil

    Toulouse, 31000

    Fabrice MUSCARI

  • Hôpital Paul-Brousse

    Villejuif, 94800

    Gabriella Pittau, PhD, 01 45 59 65 01 ext. +33, gabriella.pittau@aphp.fr

    Laurent CYLLY, laurent.cylly@aphp.fr

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer. A Randomized Controlled Trial.

The worldwide incidence of hepatobiliary and pancreatic (HPB) cancers is dramatically increasing especially for pancreatic cancer. Increasing age is associated with increased cancer risk. In North America and Europe, most people who are diagnosed with cancer every year are aged 65 years or older. Hepatectomy for hepatocellular carcinoma, intra hepatic and hilar cholangiocarcinoma, gallbladder cancer and hepatic metastases from colorectal cancer allows better survival compared to other treatments. Similarly, pancreaticoduodenectomy (PD) is the standard of care in patients with distal cholangiocarcinoma and patients with resectable pancreatic adenocarcinoma located in the head of the pancreas. This results in an increasing number of elderly patients being evaluated for hepatic and pancreatic surgery. Major hepatectomy and PD are amongst the most invasive and complex procedures in general surgery with high rates of morbidity as well as negative impact on quality of life. Many studies have reported poor post-surgical outcomes in the elderly patients, especially related to co-morbidities that characterizes this population such as, polypharmacy, cognitive decline, depression and malnutrition. The age in elderly cancer patient is not just a number. The management of these patients should not be limited to oncological care, but it should be extended to different clinical domains including physical, cognitive, psychological, socioeconomic and environmental aspects. In this population, the risk of adverse postoperative outcomes is not adequately described by routine format of current preoperative evaluation, such as age, comorbidities and other traditional tests. Furthermore, the Comprehensive Geriatric Assessment (CGA) is scarcely considered. The aim of CGA is to identify current health problems and to guide interventions thus reducing adverse outcomes and optimizing the functional status of older adults. Several trials have indeed shown that CGA and perioperative tailored interventions reduce morbidity and improve patient survival in other surgical disciplines. Similar data is lacking in both hepatic and pancreatic surgery.

The hypothesis is that CGA with perioperative tailored interventions could reduce postoperative morbidity in elderly patients after major hepatectomy and pancreaticoduodenectomy for cancer.

Being tested
Comprehensive Geriatric Assessment
Keywords
patient over 70 years, hepatocellular carcinoma, intra-hepatic and peri-hilar cholangiocarcinoma, gallbladder cancer, peri-ampullary malignant tumors, pancreatic adenocarcinoma, colorectal liver metastases, Major Hepatectomy, Pancreaticoduodenectomy
Medical subject headings
Pancreatic Neoplasms, Carcinoma, Hepatocellular, Gallbladder Neoplasms

What participants receive

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

  • Comprehensive Geriatric AssessmentProcedure or surgery

    CGA:

    • Preoperative geriatric consultation
    • Perioperative tailored intervention if needed
    • Postoperative geriatric follow-up
    • M3 geriatric consultation
Study groups in NCT06999512
Study groupRoleWhat they receive
Control groupNo interventionstandard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up
Interventional groupExperimentalstandard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up with Perioperative geriatric management: CGA, preoperative geriatric consultation, perioperative tailored intervention, postoperative geriatric follow-up
Receives: Procedure: Comprehensive Geriatric Assessment

What is being measured

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

  1. Comprehensive Complex Index (CCI) value

    Comparison of the 90-day postoperative morbidity between patients in the interventional arm (receiving preoperative CGA and perioperative tailored geriatric interventions) and those in the control arm (receiving standard of care).

    CCI is based on the Clavien-Dindo classification, and takes into account all cumulative complications and receives values between 0 (no complication) and 100 (death).

    Measured: 90 days after surgery

Secondary outcomes (17)

  1. Quality of life scale: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Quality of life will be measured at the enrolment visit (baseline) and at 3, 6 and 12 months after surgery (M3, M6 and M12), using the EORTC QLQ-C30

    Measured: at 3, 6 and 12 months post surgery

  2. Quality of life scale EQ-5D-5L

    Quality of life will be measured at the enrolment visit (baseline) and at 3, 6 and 12 months after surgery (M3, M6 and M12), using the EQ-5D-5L

    Measured: at 3, 6 and 12 months post surgery

  3. Quality of life scale ELD14

    Quality of life will be measured at the enrolment visit (baseline) and at 3, 6 and 12 months after surgery (M3, M6 and M12), using the ELD14.

    Measured: at 3, 6 and 12 months post surgery

  4. Discharge status

    Discharge status at 3 months after surgery (M3): home, rehabilitation facility, and still hospitalized or deceased

    Measured: 90 days after surgery

  5. All-cause mortality at 90 days after surgery

    90-day postoperative mortality

    Measured: at 3 months post surgery

  6. complication occurence and classification

    Occurrence of all complications classified as grade II, III, IV, according to Clavien-Dindo scale within 90 days after surgery

    Measured: at 3 months post surgery

  7. Post-operative hospital length of stay (in days)

    Post-operative hospital length of stay (in days) defined as the time from surgery to the post-operative discharge date, transfer to a subacute service or death whichever comes first.

    Measured: through study completion (an average of 5.5 years)

  8. Post-operative ICU length of stay (in days)

    Post-operative ICU length stay (in days) defined as the time from the postoperative ICU entry date to ICU discharge date or death whichever comes first.

    Measured: through study completion (an average of 5.5 years)

  9. Loss of independence at 3 months after surgery

    Loss of independence at 3 months after surgery (M3) defined by a score lower than 6/6 in ADL

    Measured: 90 days after surgery

  10. Time (in days) between the date of randomization and the date of surgery

    To compare between arms (interventional vs control arms) the delay between randomization and surgery

    Measured: from randomization to surgery, a maximum of 1 month

  11. Overall survival

    Overall survival defined as the time from surgery to death from any cause over 1 year follow-up

    Measured: at 12 months post surgery

  12. time from surgery to cancer recurrence or death from any cause

    Disease-free survival defined as the time from surgery to cancer recurrence or death from any cause over 1 year follow-up

    Measured: through study completion (an average of 5.5 years)

  13. Percentage of patients that completed the geriatric intervention

    To estimate, within the interventional arm the proportion of patients who underwent the complete geriatric intervention

    Measured: through study completion (an average of 5.5 years)

  14. Percentage of patients contraindicated to surgery after CGA

    To estimate, within the interventional arm the proportion of patients definitively contraindicated to surgery after CGA because too frail

    Measured: through study completion (an average of 5.5 years)

  15. Time (in days) between the dates of randomization and preoperative geriatric consultation

    To estimate, within the interventional arm the delay between randomization and preoperative geriatric consultation

    Measured: through study completion (an average of 5.5 years)

  16. Time (in days) between the dates of preoperative geriatric consultation and onset of tailored interventions

    To estimate, within the interventional arm the delay between preoperative geriatric consultation and tailored interventions

    Measured: through study completion (an average of 5.5 years)

  17. Time (in days) between the dates of preoperative geriatric consultation and surgery

    To estimate, within the interventional arm the delay between preoperative geriatric consultation and surgery

    Measured: through study completion (an average of 5.5 years)

Timeline

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

  1. First posted31 May 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionApr 2030 (estimated)
  4. Study completionDec 2030 (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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective comparative randomized controlled open label multicentric trial
Masking
None (open label)
Enrolment
526 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999512
Sponsor's protocol ID
APHP230898
Other IDs
ID RCB
Acronym
HPB70+
Status last verified
May 2025
First submitted
25 Apr 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: there is no plan to make individual participant data (IPD) collected in this study available.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Comprehensive Geriatric Assessment in people with Hepatobiliary Cancer and Pancreatic Cancer, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.

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 10 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Gabriella PITTAU, PhD (+33145596501 ext. +33, gabriella.pittau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comprehensive Complex Index (CCI) value (time frame: 90 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 NCT06999512.

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 31 May 2025.

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