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Outpatient Care Pathway for P...

Outpatient Care Pathway for Patients Treated Intra-arterially for Primary Liver Cancer

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepato Cellular Carcinoma (HCC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm Ambulatory care

Ambulatory care : Outpatient management of radiological treatment for HCC

Group Type EXPERIMENTAL

Ambulatory care

Intervention Type OTHER

Patients with Hepato cellular carcinoma (HCC) treated by chemo-embolization (CEH) or radioembolization (REH) are managed on an outpatient basis: hospitalization in an outpatient unit, followed by systematic telephone and on-demand nursing follow-up for 48 hours for REH and 72 hours for CEH. A dedicated re-hospitalization circuit has also been set up in the event of complications.

Arm Conventional inpatient care

Conventional inpatient care : Conventional inpatient management for radiological treatment of HCC

Group Type OTHER

Conventional inpatient care

Intervention Type OTHER

Patients with Hepato cellular carcinoma (HCC) treated by chemo-embolization (CEH) or radioembolization (REH) are managed on an inpatient basis: conventional hospitalization.

Interventions

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Ambulatory care

Intervention Type OTHER

Conventional inpatient care

Patients with Hepato cellular carcinoma (HCC) treated by chemo-embolization (CEH) or radioembolization (REH) are managed on an inpatient basis: conventional hospitalization.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* HCC or CCi diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven.
* HCC or CCi naive to intra-arterial treatment. HCC may have been previously treated with other non-intra-arterial therapies. Other HCC may have been previously treated but not with intra-arterial therapy.
* If HCC treatment is proposed at a Multidisciplinary Consultation Meeting (RCP):
* Patient Child-Pugh \< B8
* Single or multiple HCC
* Absence of lobar or truncal portal obstruction
* Absence of bile duct dilatation
* If treatment by REH proposed in RCP:
* Absence of truncal portal tumor invasion
* Uni-lobar tumor invasion (except for centrohepatic CCi)
* Total bilirubin \< 20 mg/l (or 35 µmol/L)
* Patient affiliated to or benefiting from a social security scheme
* Patient having signed an informed consent form

Exclusion Criteria

* Technical contraindication or morphological elements of predictable technical difficulty
* Chronic renal insufficiency (Clairance \< 30 ml/min)
* Known allergy to a contrast agent or chemotherapy agent
* Patient unable to be a candidate for outpatient management
* Patient previously included in the study
* Patient who, for psychological, social, family or geographical reasons, could not be regularly monitored, patient who, for psychological, social, family or geographical reasons, could not be followed regularly
* Concomitant disease or severe uncontrolled clinical situation
* Severe uncontrolled infection
* Pregnant, breast-feeding or parturient woman
* Person deprived of liberty by judicial or administrative decision
* Person under compulsory psychiatric care
* Person under a legal protection measure
* Person unable to give consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers