Outpatient Versus Inpatient Care Pathway for Intra-arterial 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

Overview

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.

Interventions

• Other 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.
• Other 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.

Primary outcome measures

• Overall patient satisfaction [Time frame: 72 hours after treatment procedure]

Secondary outcome measures (12)

• Acceptability (quantitative) [Time frame: At inclusion visit (pre-treatment)]
• Acceptability (qualitative) [Time frame: At inclusion visit (pre-treatment)]
• Adoption (quantitative) [Time frame: 32 months]
• Adoption (qualitative) [Time frame: 36 months]
• Relevance (reasons for refusal) [Time frame: 24 months]
• Relevance (patient expectations) [Time frame: 36 months]
• Feasibility of outpatient care [Time frame: One year after the end of inclusions]
• Reach (Quantitative) [Time frame: One year after the end of inclusions]
• Reach (Qualitative for centers) [Time frame: One year after the end of inclusions]
• Reach (Qualitative for patients) [Time frame: One year after the end of inclusions]
• Comparing the organizations (Pain) [Time frame: Day of procedure (baseline), evening after the procedure, and end of the care pathway (up to 72 hours, depending on treatment)]
• Comparing the organizations (Comfort and satisfaction) [Time frame: 72 hours after procedure]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 19 centers

• University hospital of Amiens — Amiens
• University hospital of Angers — Angers
• University hospital of Besançon — Besançon
• Hospital of Avicennes (AP-HP) — Bobigny
• University hospital of Brest — Brest
• Hospital of Beaujon (AP-HP) — Clichy
• Hospital of Vendée — La Roche-sur-Yon
• University hospital of Grenoble-Alpes — La Tronche
• … and 11 more centers

Identifiers

NCT: NCT06990659 · 49RC23_0306 · 2024-A02727-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗