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

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.

Overview

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.

Interventions

• Procedure Comprehensive Geriatric Assessment
  CGA: * Preoperative geriatric consultation * Perioperative tailored intervention if needed * Postoperative geriatric follow-up * M3 geriatric consultation

Primary outcome measures

• Comprehensive Complex Index (CCI) value [Time frame: 90 days after surgery]

Secondary outcome measures (12)

• 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 scale EQ-5D-5L [Time frame: at 3, 6 and 12 months post surgery]
• Quality of life scale ELD14 [Time frame: at 3, 6 and 12 months post surgery]
• Discharge status [Time frame: 90 days after surgery]
• All-cause mortality at 90 days after surgery [Time frame: at 3 months post surgery]
• complication occurence and classification [Time frame: 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 ICU length of stay (in days) [Time frame: through study completion (an average of 5.5 years)]
• Loss of independence at 3 months after surgery [Time frame: 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]
• Overall survival [Time frame: 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 12 centers

• CHU Estaing — Clermont-Ferrand
• Hôpital Bicêtre — Le Kremlin-Bicêtre
• Chru Lille - Hopital Huriez — Lille
• Hôpital Croix Rousse, HCL — Lyon
• Hôpital Edouard Herriot, HCL — Lyon
• Hôpital La Timone — Marseille
• Hôpital Cochin — Paris
• Institut Mutualiste Montsouris — Paris
• … and 4 more centers

Identifiers

NCT: NCT06999512 · APHP230898 · ID RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗