A Phase 2/3 interventional study of Comprehensive Geriatric Assessment in Hepatobiliary Cancer and Pancreatic Cancer, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 12 sites in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2/3, Interventional, and Prevention
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.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's planned enrollment of 526 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
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Exclusion Criteria:
standard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up
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
Comprehensive Complex Index (CCI) value
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).
Time frame: 90 days after surgery
Quality of life scale: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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
Time frame: at 3, 6 and 12 months post surgery
Quality of life scale EQ-5D-5L
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
Time frame: at 3, 6 and 12 months post surgery
Quality of life scale ELD14
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.
Time frame: at 3, 6 and 12 months post surgery
Discharge status
Discharge status at 3 months after surgery (M3): home, rehabilitation facility, and still hospitalized or deceased
Time frame: 90 days after surgery
All-cause mortality at 90 days after surgery
90-day postoperative mortality
Time frame: at 3 months post surgery
complication occurence and classification
Occurrence of all complications classified as grade II, III, IV, according to Clavien-Dindo scale within 90 days after surgery
Time frame: at 3 months post surgery
Post-operative hospital length of stay (in days)
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.
Time frame: through study completion (an average of 5.5 years)
Post-operative ICU length of stay (in days)
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.
Time frame: through study completion (an average of 5.5 years)
Loss of independence at 3 months after surgery
Loss of independence at 3 months after surgery (M3) defined by a score lower than 6/6 in ADL
Time frame: 90 days after surgery
Time (in days) between the date of randomization and the date of surgery
To compare between arms (interventional vs control arms) the delay between randomization and surgery
Time frame: from randomization to surgery, a maximum of 1 month
Overall survival
Overall survival defined as the time from surgery to death from any cause over 1 year follow-up
Time frame: at 12 months post surgery
time from surgery to cancer recurrence or death from any cause
Disease-free survival defined as the time from surgery to cancer recurrence or death from any cause over 1 year follow-up
Time frame: through study completion (an average of 5.5 years)
Percentage of patients that completed the geriatric intervention
To estimate, within the interventional arm the proportion of patients who underwent the complete geriatric intervention
Time frame: through study completion (an average of 5.5 years)
Percentage of patients contraindicated to surgery after CGA
To estimate, within the interventional arm the proportion of patients definitively contraindicated to surgery after CGA because too frail
Time frame: through study completion (an average of 5.5 years)
Time (in days) between the dates of randomization and preoperative geriatric consultation
To estimate, within the interventional arm the delay between randomization and preoperative geriatric consultation
Time frame: through study completion (an average of 5.5 years)
Time (in days) between the dates of preoperative geriatric consultation and onset of tailored interventions
To estimate, within the interventional arm the delay between preoperative geriatric consultation and tailored interventions
Time frame: through study completion (an average of 5.5 years)
Time (in days) between the dates of preoperative geriatric consultation and surgery
To estimate, within the interventional arm the delay between preoperative geriatric consultation and surgery
Time frame: through study completion (an average of 5.5 years)
Plan to share: No — there is no plan to make individual participant data (IPD) collected in this study available.
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