Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
Randomized multicentre trial comparing two care organisations (ambulatory vs conventional inpatient) for patients undergoing transarterial chemoembolization (TACE) or radioembolization (TARE) for primary liver cancer (Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA)). Patients are followed for 7 months to assess patient satisfaction, safety and clinical outcomes. A qualitative implementation study and a medico-economic evaluation (cost analysis and 5-years budget impact analysis) are embedded to assess acceptability, adoption, feasability, and sustainability and to inform scaling.
Eligibility criteria
Qualifiers
Age ≥ 18 years
HCC or iCCA diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven.
no prior TACE for patients included for TACE;
no prior TARE for patients included for TARE. Prior intra-arterial treatment of the other type is allowed (prior TACE before TARE, or prior TARE before TACE). Prior non-intra-arterial treatments are allowed.
Disqualifiers
Technical contraindication or morphological elements of predictable technical difficulty
Planned combined same-day therapeutic strategies at the index procedure (e.g., TACE combined with percutaneous ablation) are not allowed; sequential (non-same-day) treatments are allowed.
Chronic renal insufficiency (Clairance < 30 ml/min)
Known allergy to a contrast agent or chemotherapy agent
Trial design
Treatments tested in this trial
- Ambulatory care
- Conventional inpatient care
Treatment groups
206 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Angers
Lead sponsor
Université Paris Cité
Collaborator
Source ClinicalTrials.gov