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

NCT ID: NCT06999512

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 526 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2030-12-31

Brief 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. 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.

Conditions

Hepatobiliary Cancer; Pancreatic Cancer

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

standard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Comprehensive Geriatric Assessment

Intervention Type: PROCEDURE

CGA:

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

Interventions

Comprehensive Geriatric Assessment

CGA:

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriella PITTAU, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

CHU Estaing

Clermont-Ferrand, , France

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Chru Lille - Hopital Huriez

Lille, , France

Hôpital Croix Rousse, HCL

Lyon, , France

Hôpital Edouard Herriot, HCL

Lyon, , France

Hôpital La Timone

Marseille, , France

Hôpital Cochin

Paris, , France

Institut Mutualiste Montsouris

Paris, , France

CHU ROUEN - Site Charles Nicolle

Rouen, , France

Hôpital Rangueil

Toulouse, , France

Hôpital Paul-Brousse

Villejuif, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Central Contacts

Gabriella PITTAU, PhD

Role: CONTACT

Phone: +33145596501

Email: gabriella.pittau@aphp.fr

Facility Contacts

Gabriella Pittau, PhD

Role: primary

Laurent CYLLY

Role: backup

Other Identifiers

ID RCB

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230898

Identifier Type: -

Identifier Source: org_study_id