NCT06990659Recruiting
Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)
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
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 206 (estimated)
- First submitted
- 24 Apr 2025
- Start date
- 18 Dec 2025
- Primary completion date
- 17 Dec 2027
- Lead sponsor
- University Hospital, Angers
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06990659
What you commit to
- Study type: Interventional
- Planned participants: 206
- From 18 Dec 2025 to the primary completion date, 17 Dec 2027
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient previously included in the study
- Concomitant disease or severe uncontrolled clinical situation
Other illness
- Chronic renal insufficiency (Clairance \< 30 ml/min)
- Known allergy to a contrast agent or chemotherapy agent
- Severe uncontrolled infection
- Person under compulsory psychiatric care
Other
- 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.
- 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 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
- Pregnant, breast-feeding or parturient woman
- Person deprived of liberty by judicial or administrative decision
- Person under a legal protection measure
- Person unable to give consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| University hospital of Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| University hospital of Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Hospital of Avicennes (AP-HP) Coordinator of this site? Confirm its status | Bobigny | France | Recruiting |
| University Hospital of Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Hospital of Beaujon (AP-HP) Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Hospital of Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Recruiting |
| University hospital of Grenoble-Alpes Coordinator of this site? Confirm its status | La Tronche | France | Recruiting |
| University hospital of Marseille (AP-HM) Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Saint-Joseph Hospital Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| University Hospital of Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Not yet recruiting |
| University Hospital of Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| University Hospital of NICE Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Saint-Antoine Hospital (AP-HP) Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospital of Cochin (AP-HP) Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospital of Pitié-Salpétrière (AP-HP) Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Univesity hospital of Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| University Hospital of Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut Gustave Roussy (IGR) Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.