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NCT Number: NCT06999512

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

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.

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Key information

Conditions

Hepatobiliary Cancer Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gallbladder Diseases Gallbladder Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Estaing, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Geriatric Assessment

Procedure

CGA:

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

Primary outcomes

  1. Comprehensive Complex Index (CCI) value

    Time frame: 90 days after surgery

    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).

Secondary outcomes

  1. 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 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

  2. Quality of life scale EQ-5D-5L

    Time frame: at 3, 6 and 12 months post surgery

    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

  3. Quality of life scale ELD14

    Time frame: at 3, 6 and 12 months post surgery

    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.

  4. Discharge status

    Time frame: 90 days after surgery

    Discharge status at 3 months after surgery (M3): home, rehabilitation facility, and still hospitalized or deceased

  5. All-cause mortality at 90 days after surgery

    Time frame: at 3 months post surgery

    90-day postoperative mortality

  6. complication occurence and classification

    Time frame: at 3 months post surgery

    Occurrence of all complications classified as grade II, III, IV, according to Clavien-Dindo scale within 90 days after surgery

  7. Post-operative hospital length of stay (in days)

    Time frame: through study completion (an average of 5.5 years)

    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.

  8. Post-operative ICU length of stay (in days)

    Time frame: through study completion (an average of 5.5 years)

    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.

  9. Loss of independence at 3 months after surgery

    Time frame: 90 days after surgery

    Loss of independence at 3 months after surgery (M3) defined by a score lower than 6/6 in ADL

  10. Time (in days) between the date of randomization and the date of surgery

    Time frame: from randomization to surgery, a maximum of 1 month

    To compare between arms (interventional vs control arms) the delay between randomization and surgery

  11. Overall survival

    Time frame: at 12 months post surgery

    Overall survival defined as the time from surgery to death from any cause over 1 year follow-up

  12. time from surgery to cancer recurrence or death from any cause

    Time frame: through study completion (an average of 5.5 years)

    Disease-free survival defined as the time from surgery to cancer recurrence or death from any cause over 1 year follow-up

  13. Percentage of patients that completed the geriatric intervention

    Time frame: through study completion (an average of 5.5 years)

    To estimate, within the interventional arm the proportion of patients who underwent the complete geriatric intervention

  14. Percentage of patients contraindicated to surgery after CGA

    Time frame: through study completion (an average of 5.5 years)

    To estimate, within the interventional arm the proportion of patients definitively contraindicated to surgery after CGA because too frail

  15. Time (in days) between the dates of randomization and preoperative geriatric consultation

    Time frame: through study completion (an average of 5.5 years)

    To estimate, within the interventional arm the delay between randomization and preoperative geriatric consultation

  16. Time (in days) between the dates of preoperative geriatric consultation and onset of tailored interventions

    Time frame: through study completion (an average of 5.5 years)

    To estimate, within the interventional arm the delay between preoperative geriatric consultation and tailored interventions

  17. Time (in days) between the dates of preoperative geriatric consultation and surgery

    Time frame: through study completion (an average of 5.5 years)

    To estimate, within the interventional arm the delay between preoperative geriatric consultation and surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella PITTAU, PhD

CONTACT

[email protected]

+33145596501 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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.

Acronym: HPB70+

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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