Outpatient versus inpatient care for catheter-based treatment of primary liver cancer (CHOC)
Official title: CHOC - Implementation and Evaluation of an Ambulatory Care Pathway for Intra-arterial Treatment of Primary Liver Cancer: Study Protocol for a Multicentre Randomised Controlled Hybrid Type 1 Trial 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
Run by University Hospital, Angers · NCT06990659 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 206 (estimated) |
| Sponsor | University Hospital, Angers Government |
| Drugs / interventions | chemotherapy |
| Locations | 19 sites (Amiens and 18 other locations) |
| Status | Recruiting |
| Started | December 18, 2025 |
| Main results expected | December 17, 2027 |
| Study ends | December 17, 2028 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT06990659 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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. * Patient with HCC or iCCA eligible for intra-arterial treatment (transarterial chemoembolization \[TACE\] or transarterial radioembolization \[TARE\]), with no prior intra-arterial treatment of the same type as the one planned in the trial: * 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. * If TACE is proposed at the multidisciplinary tumour board (RCP): * Patient Child-Pugh \< B8 * Single or multiple HCC * Absence of lobar or truncal portal obstruction * Absence of bile duct dilatation * If treatment by TARE 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; sequential (non-same-day) treatments are 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 it's running
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University hospital of Amiens
Amiens, France Recruiting -
University hospital of Angers
Angers, France Recruiting -
University hospital of Besançon
Besançon, France Recruiting -
Hospital of Avicennes (AP-HP)
Bobigny, France Recruiting -
University hospital of Brest
Brest, France Recruiting -
Hospital of Beaujon (AP-HP)
Clichy, France Recruiting
Show 13 more locations
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Hospital of Vendée
La Roche-sur-Yon, France Recruiting -
University hospital of Grenoble-Alpes
La Tronche, France Recruiting -
University hospital of Marseille (AP-HM)
Marseille, France Recruiting -
Saint-Joseph Hospital
Marseille, France Recruiting -
University hospital of Nice
Nice, France Recruiting -
Saint-Antoine Hospital (AP-HP)
Paris, France Recruiting -
Hospital of Pitié-Salpétrière (AP-HP)
Paris, France Recruiting -
Hospital of Cochin (AP-HP)
Paris, France Recruiting -
University hospital of Toulouse
Toulouse, France Recruiting -
Institut Gustave Roussy (IGR)
Villejuif, France Recruiting -
University hospital of Montpellier
Montpellier, France Not yet recruiting -
University hospital of Nantes
Nantes, France Not yet recruiting -
Univesity hospital of Bordeaux
Pessac, France Not yet recruiting
Study contacts
- Principal investigator: Christophe AUBE, Pr — University Hospital, Angers
- Study coordinator: Christophe AUBE, Pr
- Email: ChAube@chu-angers.fr
- Phone: +33(0)24-135-4281
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.