Clinical trial NCT06999512: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 526
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective comparative randomized controlled open label multicentric trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Comprehensive Complex Index (CCI) value
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Quality of life scale: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: at 3, 6 and 12 months post surgery
measure: Quality of life scale EQ-5D-5L
timeFrame: at 3, 6 and 12 months post surgery
measure: Quality of life scale ELD14
timeFrame: at 3, 6 and 12 months post surgery
measure: Discharge status
timeFrame: 90 days after surgery
measure: All-cause mortality at 90 days after surgery
timeFrame: at 3 months post surgery
measure: complication occurence and classification
timeFrame: at 3 months post surgery
measure: Post-operative hospital length of stay (in days)
timeFrame: through study completion (an average of 5.5 years)
measure: Post-operative ICU length of stay (in days)
timeFrame: through study completion (an average of 5.5 years)
measure: Loss of independence at 3 months after surgery
timeFrame: 90 days after surgery
measure: Time (in days) between the date of randomization and the date of surgery
timeFrame: from randomization to surgery, a maximum of 1 month
measure: Overall survival
timeFrame: at 12 months post surgery
measure: time from surgery to cancer recurrence or death from any cause
timeFrame: through study completion (an average of 5.5 years)
measure: Percentage of patients that completed the geriatric intervention
timeFrame: through study completion (an average of 5.5 years)
measure: Percentage of patients contraindicated to surgery after CGA
timeFrame: through study completion (an average of 5.5 years)
measure: Time (in days) between the dates of randomization and preoperative geriatric consultation
timeFrame: through study completion (an average of 5.5 years)
measure: Time (in days) between the dates of preoperative geriatric consultation and onset of tailored interventions
timeFrame: through study completion (an average of 5.5 years)
measure: Time (in days) between the dates of preoperative geriatric consultation and surgery
timeFrame: through study completion (an average of 5.5 years)
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Lille
country: France
facility: Chru Lille - Hopital Huriez
city: Lyon
country: France
facility: Hôpital Croix Rousse, HCL
city: Lyon
country: France
facility: Hôpital Edouard Herriot, HCL
city: Marseille
country: France
facility: Hôpital La Timone
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Rouen
country: France
facility: CHU ROUEN - Site Charles Nicolle
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Villejuif
country: France
facility: Hôpital Paul-Brousse
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gabriella PITTAU, PhD
role: PRINCIPAL_INVESTIGATOR
References: