Clinical trial NCT06990659: Outpatient Care Pathway for Patients Treated Intra-arterially for Primary Liver Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepato Cellular Carcinoma (HCC)
Keywords: ambulatory care
hospitalization
Hepato cellular carcinoma
Patient satisfaction
randomized trial
chemoembolization
radioembolization
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Université Paris Cité
First posted: 2025-05-25
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall patient satisfaction
timeFrame: 72 hours after treatment procedure
Secondary outcomes:
measure: Acceptability (quantitative)
timeFrame: At inclusion visit (pre-treatment)
measure: Acceptability (qualitative)
timeFrame: At inclusion visit (pre-treatment)
measure: 4. Adoption (quantitative)
timeFrame: 32 months
measure: Adoption (qualitative)
timeFrame: 36 months
measure: Relevance (reasons for refusal)
timeFrame: 24 months
measure: Relevance (patient expectations)
timeFrame: 36 months
measure: Feasibility of outpatient care
timeFrame: One year after the end of inclusions
measure: Scope (Quantitative)
timeFrame: One year after the end of inclusions
measure: Scope (Qualitative for centers)
timeFrame: One year after the end of inclusions
measure: Scope (Qualitative for patients)
timeFrame: One year after the end of inclusions
measure: Comparing the organizations (Comfort and satisfaction)
timeFrame: day of surgery, evening after surgery and 10 days after treatment
measure: Comparing the organizations (Comfort and satisfaction)
timeFrame: 72 hours after treatment
measure: Comparing the organizations (Quality of life)
timeFrame: At inclusion visit (pre-treatment), Day 7, Month2/Month3 visit
measure: Comparing the organizations (General condition)
timeFrame: At inclusion visit (pre-treatment), Month2/Month3 visit
measure: Comparing the organizations (Complications)
timeFrame: Month 6
measure: Comparing the organizations (Technical succes)
timeFrame: Month2/Month3 visit, Month 6
measure: Factors for patient satisfaction (HADS)
timeFrame: Inclusion, Admission before surgery and 72 hours after treatment
measure: Factors for patient satisfaction (Disease characteristics)
timeFrame: At inclusion visit (pre-treatment)
measure: Factors for patient satisfaction (Treatment characteristics)
timeFrame: Day of treatment procedure
measure: Factors for patient satisfaction (socioeconomic)
timeFrame: At inclusion visit (pre-treatment)
measure: Factors for patient satisfaction (travel)
timeFrame: At inclusion visit (pre-treatment)
measure: Factors for patient satisfaction (comorbidities)
timeFrame: At inclusion visit (pre-treatment)
measure: Factors for patient satisfaction (ECOG)
timeFrame: At inclusion visit (pre-treatment)
measure: Factors for patient satisfaction (Quality of life)
timeFrame: At inclusion visit (pre-treatment), Day 7, Month 2/Month3
measure: Total cost of each treatment pathway
timeFrame: From day of treatment to Month 2/Month 3 visit
measure: Budgetary impact
timeFrame: 5 years after study
Other outcomes:
Locations:
city: Amiens
country: France
facility: University hospital of Amiens
city: Angers
country: France
facility: University hospital of Angers
city: Besançon
country: France
facility: University hospital of Besançon
city: Bobigny
country: France
facility: Hospital of Avicennes (AP-HP)
city: Brest
country: France
facility: University hospital of Brest
city: Clermont-Ferrand
country: France
facility: University hospital of Clermont-Ferrand
city: Clichy
country: France
facility: Hospital of Beaujon (AP-HP)
city: La Roche-sur-Yon
country: France
facility: Hospital of Vendée
city: La Tronche
country: France
facility: University hospital of Grenoble-Alpes
city: Montpellier
country: France
facility: University hospital of Montpellier
city: Nantes
country: France
facility: Nantes
city: Nice
country: France
facility: University hospital of Nice
city: Paris
country: France
facility: Hospital of Pitié-Salpétrière (AP-HP)
city: Paris
country: France
facility: Hospital of Cochin (AP-HP)
city: Pessac
country: France
facility: Univesity hospital of Bordeaux
city: Villejuif
country: France
facility: Institut Gustave Roussy (IGR)
Study officials:
affiliation: University Hospital, Angers
name: Christophe AUBE, Pr
role: PRINCIPAL_INVESTIGATOR
References: