Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer (HPB70+)

May 30, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

526

Phase

  • Phase 2
  • Phase 3

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 Locations

  • France
      • Clermont Ferrand, France, 63000
        • Chu Estaing
        • Principal Investigator:
          • Joan GAGNIERE
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpital Bicêtre
        • Principal Investigator:
          • Solafah ABDALLA
      • Lille, France, 59000
        • CHRU Lille - Hôpital Huriez
        • Principal Investigator:
          • Stéphanie TRUANT
      • Lyon, France, 69000
        • Hôpital Croix Rousse, HCL
        • Principal Investigator:
          • Jean-Yves MABRUT
      • Lyon, France, 69000
        • Hôpital Edouard Herriot, HCL
        • Principal Investigator:
          • Julie Perinel
      • Marseille, France, 13000
        • Hopital La Timone
        • Principal Investigator:
          • Sophie CHOPINET
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
        • Principal Investigator:
          • Ecoline TRIBILLON
      • Paris, France, 75014
        • Hôpital Cochin
        • Principal Investigator:
          • Ugo MARCHESE
      • Rouen, France, 76000
        • CHU ROUEN - Site Charles Nicolle
        • Principal Investigator:
          • Lilian SCHWARZ
      • Toulouse, France, 31000
        • Hôpital Rangueil
        • Principal Investigator:
          • Fabrice MUSCARI
      • Villejuif, France, 94800
        • Institut Gustave Roussy
      • Villejuif, France, 94800

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 ≥ 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
  • colorectal liver metastases
  • Needing one of the following procedures:
  • Pancreaticoduodenectomy
  • Major Hepatectomy (≥ 3 hepatic segments)

Exclusion Criteria:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
standard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up
Experimental: Interventional group
standard 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
Procedure: Comprehensive Geriatric Assessment

CGA:

  • Preoperative geriatric consultation
  • Perioperative tailored intervention if needed
  • Postoperative geriatric follow-up
  • M3 geriatric consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complex Index (CCI) value
Time Frame: 90 days after surgery

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).
90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life scale: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame: at 3, 6 and 12 months post surgery
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
at 3, 6 and 12 months post surgery
Quality of life scale EQ-5D-5L
Time Frame: at 3, 6 and 12 months post surgery
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
at 3, 6 and 12 months post surgery
Quality of life scale ELD14
Time Frame: at 3, 6 and 12 months post surgery
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.
at 3, 6 and 12 months post surgery
Discharge status
Time Frame: 90 days after surgery
Discharge status at 3 months after surgery (M3): home, rehabilitation facility, and still hospitalized or deceased
90 days after surgery
All-cause mortality at 90 days after surgery
Time Frame: at 3 months post surgery
90-day postoperative mortality
at 3 months post surgery
complication occurence and classification
Time Frame: at 3 months post surgery
Occurrence of all complications classified as grade II, III, IV, according to Clavien-Dindo scale within 90 days after surgery
at 3 months post surgery
Post-operative hospital length of stay (in days)
Time Frame: through study completion (an average of 5.5 years)
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.
through study completion (an average of 5.5 years)
Post-operative ICU length of stay (in days)
Time Frame: through study completion (an average of 5.5 years)
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.
through study completion (an average of 5.5 years)
Loss of independence at 3 months after surgery
Time Frame: 90 days after surgery
Loss of independence at 3 months after surgery (M3) defined by a score lower than 6/6 in ADL
90 days after surgery
Time (in days) between the date of randomization and the date of surgery
Time Frame: from randomization to surgery, a maximum of 1 month
To compare between arms (interventional vs control arms) the delay between randomization and surgery
from randomization to surgery, a maximum of 1 month
Overall survival
Time Frame: at 12 months post surgery
Overall survival defined as the time from surgery to death from any cause over 1 year follow-up
at 12 months post surgery
time from surgery to cancer recurrence or death from any cause
Time Frame: through study completion (an average of 5.5 years)
Disease-free survival defined as the time from surgery to cancer recurrence or death from any cause over 1 year follow-up
through study completion (an average of 5.5 years)
Percentage of patients that completed the geriatric intervention
Time Frame: through study completion (an average of 5.5 years)
To estimate, within the interventional arm the proportion of patients who underwent the complete geriatric intervention
through study completion (an average of 5.5 years)
Percentage of patients contraindicated to surgery after CGA
Time Frame: through study completion (an average of 5.5 years)
To estimate, within the interventional arm the proportion of patients definitively contraindicated to surgery after CGA because too frail
through study completion (an average of 5.5 years)
Time (in days) between the dates of randomization and preoperative geriatric consultation
Time Frame: through study completion (an average of 5.5 years)
To estimate, within the interventional arm the delay between randomization and preoperative geriatric consultation
through study completion (an average of 5.5 years)
Time (in days) between the dates of preoperative geriatric consultation and onset of tailored interventions
Time Frame: through study completion (an average of 5.5 years)
To estimate, within the interventional arm the delay between preoperative geriatric consultation and tailored interventions
through study completion (an average of 5.5 years)
Time (in days) between the dates of preoperative geriatric consultation and surgery
Time Frame: through study completion (an average of 5.5 years)
To estimate, within the interventional arm the delay between preoperative geriatric consultation and surgery
through study completion (an average of 5.5 years)

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Gabriella PITTAU, PhD, Assistance Publique - Hôpitaux de Paris

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)

September 1, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

May 30, 2025

First Posted (Actual)

May 31, 2025

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP230898
  • ID RCB (Other Identifier: 2026-A00246-45)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there is no plan to make individual participant data (IPD) collected in this study available.

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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