Actively Recruiting
Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer: Randomized Multicenter Trial
Led by University Hospital, Angers · Updated on 2026-03-11
206
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Angers
Lead Sponsor
U
Université Paris Cité
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two ways of caring for patients with primary liver cancer, specifically Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA), who undergo treatments called transarterial chemoembolization (TACE) or radioembolization (TARE). This randomized multicenter trial aims to assess patient satisfaction, safety, and clinical outcomes over a follow-up period of 7 months. The study also includes a qualitative implementation assessment and an economic evaluation to understand how acceptable, feasible, and sustainable outpatient care is compared to conventional inpatient care. The trial has two groups: one where patients receive ambulatory care, meaning they are treated as outpatients with follow-up phone calls and nursing support for 48 to 72 hours after treatment depending on the procedure, and another where patients receive conventional inpatient care with traditional hospitalization during treatment. If complications arise in the outpatient group, a special re-hospitalization plan is in place. These care pathways are compared for comfort, satisfaction, quality of life, complications, and costs. Participants will be evaluated before treatment and monitored through various visits up to 7 months after the procedure. Assessments include patient satisfaction within 72 hours post-treatment, quality of life, general condition, technical success of treatment, and any complications. The study also records economic data and long-term budget impact. Patients' adherence and safety are monitored, and outcome measures include both quantitative and qualitative evaluations to thoroughly compare outpatient and inpatient care models in this patient population.
CONDITIONS
Brief Title
Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) based on European Association for the Study of the Liver criteria or histology
- No prior intra-arterial treatment for HCC or iCCA
- If treatment proposed at Multidisciplinary Consultation Meeting (RCP): Child-Pugh score less than B8, single or multiple HCC, no lobar or truncal portal obstruction, no bile duct dilation
- For radioembolization treatment proposal: no truncal portal tumor invasion, uni-lobar tumor invasion (except centrohepatic iCCA), total bilirubin less than 20 mg/l (or 35 µmol/L)
- Affiliated with or benefiting from a social security scheme
- Signed informed consent form
You will not qualify if you...
- Technical contraindication or predictable technical difficulty
- Planned combined same-day therapies at the procedure (e.g., TACE with percutaneous ablation)
- Chronic renal insufficiency with clearance less than 30 ml/min
- Known allergy to contrast or chemotherapy agents
- Inability to participate in outpatient care (lack of understanding, no reliable phone, no responsible adult for first night, or no timely urgent care access)
- Previously included in this study
- Psychological, social, family, or geographical reasons preventing regular monitoring
- Severe uncontrolled clinical diseases or infections
- Pregnant, breastfeeding, or just given birth
- Person deprived of liberty by judicial or administrative decision
- Under compulsory psychiatric care
- Under legal protection measures
- Unable to give consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours post-procedure
Participants receive intra-arterial treatment for primary liver cancer either through outpatient ambulatory care with follow-up phone and nursing support for 48 to 72 hours or through conventional inpatient hospitalization.
1 treatment visit followed by telephone and on-demand nursing follow-up within 48 to 72 hours
Duration - Up to 6 months
Participants are monitored for outcomes such as patient satisfaction, quality of life, complications, and treatment success up to 6 months after treatment.
Visits at Day 7, Month 2/3, and Month 6
Trial Site Locations
Total: 14 locations
1
University hospital of Amiens
Amiens, France, 80054
Not Yet Recruiting
2
University hospital of Angers
Angers, France, 49933
Actively Recruiting
3
University hospital of Besançon
Besançon, France, 25030
Actively Recruiting
4
Hospital of Avicennes (AP-HP)
Bobigny, France
Not Yet Recruiting
5
University hospital of Brest
Brest, France, 29609
Not Yet Recruiting
6
Hospital of Beaujon (AP-HP)
Clichy, France, 92110
Actively Recruiting
7
Hospital of Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
8
University hospital of Grenoble-Alpes
La Tronche, France, 38700
Not Yet Recruiting
9
University hospital of Montpellier
Montpellier, France, 34090
Not Yet Recruiting
10
University hospital of Nice
Nice, France, 06202
Actively Recruiting
11
Hospital of Pitié-Salpétrière (AP-HP)
Paris, France, 75013
Actively Recruiting
12
Hospital of Cochin (AP-HP)
Paris, France, 75014
Actively Recruiting
13
Univesity hospital of Bordeaux
Pessac, France, 33607
Not Yet Recruiting
14
Institut Gustave Roussy (IGR)
Villejuif, France, 94805
Actively Recruiting
Research Team
C
Christophe AUBE, Pr
S
Sandra MERZEAU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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