Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06999512 (HPB70+) for Hepatobiliary Cancer, Pancreatic Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
Assistance Publique - Hôpitaux de ParisImpact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer (HPB70+) Phase 2, Phase 3 526 Senior-Focused
Clinical Trial NCT06999512 (HPB70+) is designed to study Prevention for Hepatobiliary Cancer, Pancreatic Cancer. This Phase 2 Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 September 2025 until the study accrues 526 participants. Led by Assistance Publique - Hôpitaux de Paris, this study is expected to complete by 1 December 2030. The latest data from ClinicalTrials.gov was last updated on 31 May 2025.
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 metas...Show More
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.
Conditions
Hepatobiliary CancerPancreatic CancerOther Study IDs
- HPB70+
- APHP230898
- ID RCB (Other Identifier) (2024-A00038-39)
NCT ID Number
Start Date (Actual)
2025-09
Last Update Posted
2025-05-31
Completion Date (Estimated)
2030-12
Enrollment (Estimated)
526
Study Type
Interventional
PHASE
Phase 2
Phase 3
Phase 3
Status
Not yet recruiting
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
hepatocellular carcinoma
intra-hepatic and peri-hilar cholangiocarcinoma
gallbladder cancer
peri-ampullary malignant tumors
pancreatic adenocarcinoma
colorectal liver metastases
Major Hepatectomy
Pancreaticoduodenectomy
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionControl group standard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up | N/A |
ExperimentalInterventional group 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 | Comprehensive Geriatric Assessment CGA:
* Preoperative geriatric consultation
* Perioperative tailored intervention if needed
* Postoperative geriatric follow-up
* M3 geriatric consultation |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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 | 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. | 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 | 90 days after surgery |
All-cause mortality at 90 days after surgery | 90-day postoperative mortality | 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 | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | through study completion (an average of 5.5 years) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Older Adult
Minimum Age
70 Years
Eligible Sexes
All
- 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)
- 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
Assistance Publique - Hôpitaux de Paris967 active studies to exploreStudy Central Contact
Contact: Gabriella PITTAU, PhD, +33145596501, [email protected]
12 Study Locations in 1 Countries
CHU Estaing, Clermont-Ferrand, 63000, France
Joan GAGNIERE, Principal Investigator
Hôpital Bicêtre, Le Kremlin-Bicêtre, 94270, France
Solafah ABDALLA, Principal Investigator
Chru Lille - Hopital Huriez, Lille, 59000, France
Stéphanie TRUANT, Principal Investigator
Hôpital Croix Rousse, HCL, Lyon, 69000, France
Jean-Yves MABRUT, Principal Investigator
Hôpital Edouard Herriot, HCL, Lyon, 69000, France
Julie Perinel, Principal Investigator
Hôpital La Timone, Marseille, 13000, France
Sophie CHOPINET, Principal Investigator
Hôpital Cochin, Paris, 75014, France
Ugo MARCHESE, Principal Investigator
Institut Mutualiste Montsouris, Paris, 75014, France
Ecoline TRIBILLON, Principal Investigator
CHU ROUEN - Site Charles Nicolle, Rouen, 76000, France
Lilian SCHWARZ, Principal Investigator
Hôpital Rangueil, Toulouse, 31000, France
Fabrice MUSCARI, Principal Investigator
Hôpital Paul-Brousse, Villejuif, 94800, France
Gabriella Pittau, PhD, Contact, 01 45 59 65 01, [email protected]
Laurent CYLLY, Contact, [email protected]
Institut Gustave Roussy, Villejuif, 94800, France