Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 9:01 AM
Study NCT ID:
NCT06990659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Care Pathway for Patients Treated Intra-arterially for Primary Liver Cancer
Sponsor:
University Hospital, Angers
Organization:
Study Overview
Official Title:
CHOC - Implémentation et évaluation d'un Parcours de Soin Ambulatoire Pour Les Patients traités Par Voie Intra-artérielle d'un Cancer Primitif du Foie : Essai Multicentrique contrôlé randomisé
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHOC
Brief Summary:
Randomized trial comparing two care organizations (outpatient versus conventional inpatient care) using a mixed method (quantitative and qualitative data and analysis).
The protocol involves randomization between an ambulatory group and a conventional hospitalization group. Patients will be monitored for 7 months to assess satisfaction, complications and treatment efficacy. A qualitative study will be carried out to understand the obstacles and facilitate implementation of the ambulatory pathway. A medico-economic analysis will accompany this study to assess the financial impact of adopting the ambulatory pathway. The expected results will help determine the best management strategy for these patients.
The study's hypotheses are that performing intra-arterial treatments for primary liver cancer on an outpatient basis, combined with telephone follow-up, will improve patient satisfaction with their care, and that analysis of the implementation of this outpatient pathway will help improve the pathway and facilitate its implementation at other sites, by identifying obstacles and solutions.
The protocol involves randomization between an ambulatory group and a conventional hospitalization group. Patients will be monitored for 7 months to assess satisfaction, complications and treatment efficacy. A qualitative study will be carried out to understand the obstacles and facilitate implementation of the ambulatory pathway. A medico-economic analysis will accompany this study to assess the financial impact of adopting the ambulatory pathway. The expected results will help determine the best management strategy for these patients.
The study's hypotheses are that performing intra-arterial treatments for primary liver cancer on an outpatient basis, combined with telephone follow-up, will improve patient satisfaction with their care, and that analysis of the implementation of this outpatient pathway will help improve the pathway and facilitate its implementation at other sites, by identifying obstacles and solutions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A02727-40 | OTHER | ANSM | View |