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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
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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University Hospital of Amiens
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AmiensFranceRecruiting
University hospital of Angers
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AngersFranceRecruiting
University hospital of Besançon
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BesançonFranceRecruiting
Hospital of Avicennes (AP-HP)
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BobignyFranceRecruiting
University Hospital of Brest
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BrestFranceRecruiting
Hospital of Beaujon (AP-HP)
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ClichyFranceRecruiting
Hospital of Vendée
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La Roche-sur-YonFranceRecruiting
University hospital of Grenoble-Alpes
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La TroncheFranceRecruiting
University hospital of Marseille (AP-HM)
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MarseilleFranceRecruiting
Saint-Joseph Hospital
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MarseilleFranceRecruiting
University Hospital of Montpellier
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MontpellierFranceNot yet recruiting
University Hospital of Nantes
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NantesFranceNot yet recruiting
University Hospital of NICE
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NiceFranceRecruiting
Saint-Antoine Hospital (AP-HP)
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ParisFranceRecruiting
Hospital of Cochin (AP-HP)
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ParisFranceRecruiting
Hospital of Pitié-Salpétrière (AP-HP)
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ParisFranceRecruiting
Univesity hospital of Bordeaux
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PessacFranceNot yet recruiting
University Hospital of Toulouse
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ToulouseFranceRecruiting
Institut Gustave Roussy (IGR)
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VillejuifFranceRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.