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

Assistance Publique - Hôpitaux de Paris

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Hepatobiliary Cancer; Pancreatic Cancer

Treatments: Procedure: Comprehensive Geriatric Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06999512

APHP230898

ID RCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 526 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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526 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Interventional group

Experimental group

Description:

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

Treatment:

Procedure: Comprehensive Geriatric Assessment