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

NCT06999512 | Not Yet Recruiting Phase 2

• 2 other identifiers: APHP230898ID RCB
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 12

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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  90 days after surgery

Secondary Outcomes (17)

• Quality of life scale: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  at 3, 6 and 12 months post surgery

• Quality of life scale EQ-5D-5L

  at 3, 6 and 12 months post surgery

• Quality of life scale ELD14

  at 3, 6 and 12 months post surgery

• Discharge status

  90 days after surgery

• All-cause mortality at 90 days after surgery

  at 3 months post surgery

Study Arms (2)

Control group

NO INTERVENTION

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

Interventional group

EXPERIMENTAL

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

Interventions

Comprehensive Geriatric Assessment PROCEDURE

CGA: * Preoperative geriatric consultation * Perioperative tailored intervention if needed * Postoperative geriatric follow-up * M3 geriatric consultation

Interventional group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (12)

CHU Estaing

Clermont-Ferrand, 63000, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Chru Lille - Hopital Huriez

Lille, 59000, France

Location

Hôpital Croix Rousse, HCL

Lyon, 69000, France

Location

Hôpital Edouard Herriot, HCL

Lyon, 69000, France

Location

Hôpital La Timone

Marseille, 13000, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

CHU ROUEN - Site Charles Nicolle

Rouen, 76000, France

Location

Hôpital Rangueil

Toulouse, 31000, France

Location

Hôpital Paul-Brousse

Villejuif, 94800, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Carcinoma, Hepatocellular; Gallbladder Neoplasms

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Gabriella PITTAU, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella PITTAU, PhD

CONTACT

+33145596501; gabriella.pittau@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective comparative randomized controlled open label multicentric trial

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)