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NCT Number: NCT06990659

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

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.

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Key information

Conditions

Hepato Cellular Carcinoma (HCC) Adenocarcinoma Behavior Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Health Behavior Intrahepatic Cholangiocarcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulatory care

Other

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

Other

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 outcomes

  1. Overall patient satisfaction

    Time frame: 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.

Secondary outcomes

  1. Acceptability (quantitative)

    Time frame: At inclusion visit (pre-treatment)

    Proportion of consenting patients and description of refusals

  2. Acceptability (qualitative)

    Time frame: At inclusion visit (pre-treatment)

    Thematic analysis of individual research interviews with a sample of patients included in both arms of the study.

  3. Adoption (quantitative)

    Time frame: 32 months

    Number of outpatient courses completed compared with the number of scheduled courses; number of candidate, open and active centers.

  4. Adoption (qualitative)

    Time frame: 36 months

    Thematic analysis of verbatims collected during focus groups with centers

  5. Relevance (reasons for refusal)

    Time frame: 24 months

    Characteristics of patients whose inclusion in the protocol was refused by the patient/carer.

  6. Relevance (patient expectations)

    Time frame: 36 months

    Thematic content analysis of verbatims collected during individual research interviews with patients in both arms, in order to understand the patient experience throughout the treatment period, and to identify needs and expectations in terms of post-intervention follow-up in both groups.

  7. Feasibility of outpatient care

    Time frame: One year after the end of inclusions

    Proportion of outpatient treatments planned and then cancelled, reasons for non-implementation, perception of obstacles and facilitators via individual interviews and focus groups with caregivers.

  8. Reach (Quantitative)

    Time frame: One year after the end of inclusions

    Patient-related factors associated with ambulatory care pathway failure (Indication; Techniques; Tolerance of organization).

  9. Reach (Qualitative for centers)

    Time frame: One year after the end of inclusions

    thematic analysis of verbatims collected in the focus group, focusing on elements identified by caregivers as having contributed to organizational changes to enable implementation of the ambulatory pathway. Elements perceived as obstacles to change will also be identified and analyzed by theme

  10. Reach (Qualitative for patients)

    Time frame: One year after the end of inclusions

    thematic analysis of verbatims collected during post-treatment interviews, focusing on elements identified by patients as having contributed to their continued health after returning home. Elements relating to improvements to be made to the ambulatory care pathway will also be recorded and analyzed by theme

  11. 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)

    Visual analogue scale (VAS) for pain : 0 ('no pain') to 10 ('pain as bad as it could possibly be')

  12. Comparing the organizations (Comfort and satisfaction)

    Time frame: 72 hours after procedure

    Quality Of Life Questionnaire - Satisfaction with Cancer Care - Core questionnaire (EORTC QLQ-PATSAT-C33) for all and specific complementary outpatient module (OUT-PATSAT7) for the outpatient group.

    Items are rated from 1 (bad) to 5 (Excellent)

  13. Comparing the organizations (Quality of life)

    Time frame: At inclusion visit (pre-treatment), Day 7, Month2/Month3 visit

    Medical Outcome Study Short Form 12 (SF-12) A score >50 indicates above-average health-related quality of life

  14. Comparing the organizations (General condition)

    Time frame: At inclusion visit (pre-treatment), Month2/Month3 visit

    Patient's general condition assessed by clinical status (Eastern Cooperative Oncology Group ECOG) from 0 (Fully active, able to carry on all pre-disease performance without restriction) to 5 (dead)

  15. Comparing the organizations (Complications)

    Time frame: Month 6

    Complications according to the Common Terminology Criteria for Adverse Events (CTCAE) V5.0.5 Items from 1 (mild) to 5 (death)

  16. Comparing the organizations (Technical succes)

    Time frame: Month2/Month3 visit, Month 6

    Technical success defined by completion of the planned procedure. Tumour response according to mRECIST and LI-RADS TRA 2024 (non-evaluable, non-viable, non-progressor, viable)

  17. Factors for patient satisfaction (HADS)

    Time frame: Inclusion, Admission before surgery and 72 hours after procedure

    Anxiety and depression scale (HADS)

  18. Factors for patient satisfaction (Disease characteristics)

    Time frame: At inclusion visit (pre-treatment)

    Barcelona Clinic Liver Cancer (BCLC) classification stage, sarcopenia (based on imaging).

  19. Factors for patient satisfaction (Treatment characteristics)

    Time frame: Day of treatment procedure

    • for transarterial chemoembolization (TACE) : selectivity, number of segments treated, % of chemotherapy injected, additional embolization;
    • for transarterial radioembolization (TARE): number of injection sites;
    • for all: procedure duration, center volume, operator volume, treatment line, combination treatment.

  20. Factors for patient satisfaction (socioeconomic)

    Time frame: At inclusion visit (pre-treatment)

    Socioeconomic level

  21. Factors for patient satisfaction (travel)

    Time frame: At inclusion visit (pre-treatment)

    Home-hospital travel time

  22. Factors for patient satisfaction (comorbidities)

    Time frame: At inclusion visit (pre-treatment)

    Comorbidities

  23. Factors for patient satisfaction (ECOG)

    Time frame: At inclusion visit (pre-treatment)

    Clinical status (ECOG)

  24. Factors for patient satisfaction (Quality of life)

    Time frame: At inclusion visit (pre-treatment), Day 7, Month 2/Month3

    Questionnary of quality of life = Medical Outcome Study Short Form 12 (SF-12)

  25. Total cost of each treatment pathway

    Time frame: From day of treatment to Month 2/Month 3 visit

    From the community, health insurance and hospital perspective (depending on the type of treatment received)

  26. Budgetary impact

    Time frame: 5 years after study

    Annual and cumulative 5-year budgetary impact of changing clinical practices towards outpatient management of patients treated intra-arterially for hepatocellular carcinoma, from a health insurance perspective

  27. Ambulatory pathway failure

    Time frame: within 72 hours post-procedure

    unplanned hospital admission after the procedure (including same-day unplanned admission), delayed discharge when same-day discharge criteria are not met, or hospital readmission within the predefined early post-procedural window (72 hours)

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe AUBE, Pr

CONTACT

[email protected]

+33(0)24-135-4281

Sandra MERZEAU

CONTACT

[email protected]

+33(0)24-135-5970

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Université Paris Cité

Registry information

Official study 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

Acronym: CHOC

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 25, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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