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Recruiting Not applicable

Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)

NCT06990659 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-12-18
Last updated
2026-07-17

Condition(s) studied

Hepato Cellular Carcinoma (HCC)Intrahepatic Cholangiocarcinoma

Investigational drug(s) / intervention(s)

Ambulatory careConventional inpatient care

Ambulatory care: Patients with Hepato cellular carcinoma (HCC) and Intrahepatic cholangiocarcinoma (iCCA) treated by transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) are managed on an outpatient basis: hospitalization in an outpatient unit, followed by systematic telephone and on-demand nursing follow-up for 48 hours for TARE and 72 hours for TACE. A dedicated re-hospitalization circuit has also been set up in the event of complications.

Conventional inpatient care: Patients with Hepato cellular carcinoma (HCC) and Intrahepatic cholangiocarcinoma treated by transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) are managed on an inpatient basis: conventional hospitalization.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Overall patient satisfaction — 72 hours after treatment procedure
    EORTC PATSAT-C33 questionnaire. All items are scored 1 (bad) to 5 (excellent). The total score measures range in score from 0 to 100. A high score represents a high level of satisfaction with care / perceived care quality.

Trial sites (19)

FacilityCityRegionStatus
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
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 Montpellier Montpellier France Not Yet Recruiting
University hospital of Nantes Nantes France Not Yet 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
Univesity hospital of Bordeaux Pessac France Not Yet Recruiting
University hospital of Toulouse Toulouse France Recruiting
Institut Gustave Roussy (IGR) Villejuif France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06990659 on ClinicalTrials.gov ↗ ← All trials in France