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 groups

Locations

19
University hospital of Amiens80054, Amiens France
University hospital of Angers49933, Angers France
University hospital of Besançon25030, Besançon France
Hospital of Avicennes (AP-HP) Bobigny France

Sponsors and collaborators

University Hospital, Angers

Lead sponsor

Université Paris Cité

Collaborator