NCT06999512Not yet recruitingPhase 2/3
Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer
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.
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 526 (estimated)
- First submitted
- 25 Apr 2025
- Start date
- Sept 2025
- Primary completion date
- Apr 2030
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- NCT number
- NCT06999512
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 526
- From Sept 2025 to the primary completion date, Apr 2030
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Chru Lille - Hopital Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital Croix Rousse, HCL Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Edouard Herriot, HCL Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU ROUEN - Site Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hopital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Hôpital Paul-Brousse Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.