Home › Trials › NCT06990659

Outpatient versus inpatient care for catheter-based treatment of primary liver cancer (CHOC)

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

Not applicable Interventional University Hospital, Angers · NCT06990659

This trial will see if having TACE or TARE as an outpatient (ambulatory) procedure is as safe and more satisfying than staying in the hospital for adults with hepatocellular carcinoma or intrahepatic cholangiocarcinoma.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment206 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Angers Government
Drugs / interventionschemotherapy
Locations14 sites (Amiens and 13 other locations)
Trial IDNCT06990659 on ClinicalTrials.gov

What this trial studies

This is a randomized, multicenter comparison of two care pathways — ambulatory (same-day discharge) versus conventional inpatient admission — for patients receiving intra-arterial treatments (TACE or TARE) for primary liver cancer. Participants are followed for seven months to measure patient satisfaction, safety events, and clinical outcomes. The trial embeds a qualitative implementation study and a medico-economic analysis, including cost analysis and a five-year budget impact assessment, to evaluate feasibility, acceptability, adoption, and sustainability. Eligible patients are adults with HCC or iCCA planned for first intra-arterial therapy who meet liver-function and anatomic criteria defined by the trial.

Who should consider this trial

Good fit: Adults (≥18) with HCC or intrahepatic cholangiocarcinoma planned for first intra-arterial therapy (TACE or TARE) who meet the trial's liver-function and anatomic criteria (for example Child-Pugh < B8 and no major portal trunk invasion or bile duct dilatation) are ideal candidates.

Not a fit: Patients with technical contraindications, advanced liver dysfunction (Child-Pugh ≥ B8), truncal portal tumor invasion, significant biliary dilation, or other reasons requiring inpatient monitoring are unlikely to benefit from the outpatient pathway.

Why it matters

Potential benefit: If successful, the outpatient pathway could allow more patients to avoid overnight hospitalization, improving patient experience and reducing costs while maintaining safety.

How similar studies have performed: Some single-center and observational reports suggest ambulatory management after loco-regional liver procedures can be safe and acceptable, but randomized multicenter evidence remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.
* HCC or iCCA naive to intra-arterial treatment. HCC or iCCA 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 ou iCCA 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 iCCA)
* 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
* Planned combined same day therapeutic strategies at the index procedure (e.g., TACE combined with percutaneous ablation) are not allowed
* Chronic renal insufficiency (Clairance \< 30 ml/min)
* Known allergy to a contrast agent or chemotherapy agent
* inability to participate in ambulatory care (inability to understand and follow discharge instructions, lack of reliable telephone access, absence of a responsible accompanying adult for the first night after discharge, or inability to access urgent care in a timely manner if symptoms occur)
* 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

Where this trial is running

Amiens and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepato Cellular CarcinomaIntrahepatic Cholangiocarcinomaambulatory carehospitalizationHepato cellular carcinomaPatient satisfactionrandomized trialchemoembolization
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.