Abstract
Introduction
Primary liver cancers, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, are one of the leading causes of cancer-related mortality. Transarterial chemoembolisation (TACE) and radioembolisation (TARE) are established palliative treatments yet they are traditionally performed during inpatient hospitalisation. Recent technical and organisational advances allow for safe same-day ambulatory procedures. In particular, the extent to which ambulatory intra-arterial therapy aligns with patients’ expectations, comfort and quality of life remains poorly documented. The Care pathway for Hepatic intra-arterial Oncology in an ambulatory Context study (CHOC) trial aims to evaluate the implementation and effectiveness from both patient-centred and clinical perspectives of an ambulatory care pathway for intra-arterial treatment of primary liver cancer in a multicentre randomised hybrid type 1 trial.
Methods and analysis
CHOC is a pragmatic, multicentre, randomised controlled hybrid type 1 trial comparing ambulatory versus conventional inpatient care for patients undergoing TACE or TARE for primary liver cancer. A total of 206 patients (103 per arm) will be randomised 1:1 and followed for 7 months. The primary outcome is the patient’s global satisfaction score, measured 3 days post-procedure using the EORTC PATSAT-C33 questionnaire. Secondary outcomes include quality of life, safety, clinical outcomes, cost analysis and an embedded qualitative implementation study assessing acceptability, adoption, feasibility and sustainability across centres. Economic analyses will estimate both per-patient costs and the 5-year budget impact for the French national health insurance.
Ethics and dissemination
The study has received ethical approval from the Protection of Persons Committee and adheres to the Declaration of Helsinki, good clinical practice and French regulatory requirements. Findings will be disseminated through peer-reviewed publications, conferences and participating centres to guide broader implementation of ambulatory interventional radiology care.
Trial registration number
Keywords: Implementation Science, Health Care Costs, Interventional radiology, Hepatobiliary tumours, Patient-Centered Care, Patient Satisfaction
STRENGTHS AND LIMITATIONS OF THIS STUDY.
First multicentre randomised hybrid trial evaluating ambulatory intra-arterial treatment of liver cancer.
Integrates quantitative and qualitative methodologies to assess both effectiveness and real-world implementation.
Strong patient-centred design measuring satisfaction and quality of life using validated EORTC tools.
Includes a full medico-economic analysis (cost analysis and budget impact analysis), providing robust evidence for potential national scaling in the French healthcare system.
Limited to French centres, which may restrict generalisability to other healthcare systems.
Introduction
Primary liver cancers, encompassing hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (iCCA), represent the third leading cause of cancer-related death worldwide. In France, approximately 10 500 new HCC cases and 8700 related deaths were reported in 2018. While curative treatments such as resection, ablation or transplantation are available for early-stage disease, most patients present with unresectable tumours at intermediate or advanced stages, for which transarterial therapies—chemoembolisation (TACE) or radioembolisation (TARE)—are the standard of care.1 2
Traditionally, these procedures are performed during hospital stays of 24–72 hours to allow post-procedural monitoring and management of potential complications such as post-embolisation syndrome or vascular access issues. However, innovations in procedural safety and peri-procedural care—including radial arterial access, improved embolic selectivity and streamlined post-treatment monitoring—have enabled a shift toward same-day ambulatory management.3–7
Ambulatory interventional radiology is increasingly recognised as a component of patient-centred care, promoting autonomy and reducing hospital burden without compromising safety. Preliminary evidence supports the safety and feasibility of same-day TARE and selective TACE procedures, with comparable efficacy and reduced costs.8 9 Despite this, adoption remains limited in France due to organisational, regulatory and economic constraints. At the same time, patients’ perspectives on ambulatory intra-arterial treatment—particularly among frail individuals—remain largely undocumented. Understanding whether ambulatory care genuinely aligns with patients’ expectations, comfort and quality-of-life priorities is therefore essential and directly motivates the Care pathway for Hepatic intra-arterial Oncology in an ambulatory Context study (CHOC) trial.
In 2022, a national survey by the French Society of Abdominal and Digestive Imaging and the French Society of Cardiovascular Imaging revealed that only 13% of responding centres performed ambulatory intra-arterial procedures, though 68% expressed intent to develop such pathways within 2 years.10 These findings highlight both a strong interest from clinicians and persistent barriers to implementation, underscoring the need for robust evidence for national deployment.
The CHOC study was therefore designed to address these gaps by generating high-level evidence on both clinical effectiveness and the real-world implementation of ambulatory care. It aims to determine whether ambulatory management improves patient satisfaction compared with conventional hospitalisation and to assess feasibility, acceptability, safety and implementation across diverse clinical settings.
Objectives
The primary objective is to compare overall patient satisfaction between ambulatory and conventional inpatient intra-arterial treatments for primary liver cancer.
Secondary objectives
Secondary objectives are to evaluate the implementation process, including acceptability, adoption, feasibility, relevance and sustainability; to compare patient-reported outcomes, namely comfort, satisfaction and quality of life; to assess clinical outcomes, including safety, technical success and tumour response; to identify factors influencing patient satisfaction and the success of the care pathway and to conduct cost and budget impact analyses from the hospital, payer and societal perspectives.
Methods and analysis
Study design
CHOC is a multicentre, parallel-group, randomised controlled hybrid type 1 trial integrating both effectiveness and implementation outcomes.11 12 Patients are randomised in a 1:1 ratio to either an ambulatory care pathway or a conventional inpatient care pathway, with stratification by treatment type (TACE vs TARE) and by centre experience (≥30 vs <30 procedures per year). For patients treated by TARE, randomisation is additionally stratified by the centre’s organisation for the preparatory angiography (performed as an outpatient procedure or during an inpatient admission).
The trial follows SPIRIT 2024 guidelines and is registered on ClinicalTrials.gov (NCT06990659).
A qualitative implementation study and an economic evaluation are embedded within the trial.
The design aims to capture both clinical outcomes and the real-world feasibility, acceptability and scalability of an ambulatory intra-arterial care pathway.
Setting and participants
Patients will be recruited from French interventional radiology departments authorised to perform intra-arterial liver cancer therapies. All inclusion and exclusion criteria are pre-specified in the study protocol before participant recruitment.
Inclusion criteria
Eligible participants are adults (≥18 years) with HCC or iCCA diagnosed according to the EASL 2024 non-invasive criteria or histology who are naïve to intra-arterial therapy.1 Patients must have an indication for TACE or TARE confirmed in a multidisciplinary tumour board, Child–Pugh score <B8 and (for TARE) bilirubin <35 µmol/L. Participants must be affiliated with the French social security system and provide signed informed consent.
Exclusion criteria
Severe renal impairment, uncontrolled infection, pregnancy, legal protection measures, inability to participate in the ambulatory pathway, operationally defined as 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 occur13 14
All eligibility criteria were pre-specified in the protocol prior to recruitment and will not be modified during the study; the full list of inclusion and exclusion criteria is provided in online supplemental material 1.
Recruitment
Participants will be approached during routine clinical consultations by the interventional radiology or hepatology team. Written and oral information will be provided, and written informed consent will be obtained prior to enrolment (online supplemental material 2).
To assess potential selection and improve transparency, each centre will complete a standardised screening log documenting, for eligible patients who are not managed as ambulatory, the primary reason(s) (medical reasons, comprehension/communication barrier, home support constraints, access/logistics constraints, patient preference, organisational constraints or other).
Study timeline
Recruitment will start in January 2026 and end in December 2027. Participants will be followed for up to 7 months after treatment; therefore, the end of follow-up is anticipated for July 2028.
Interventions
Ambulatory care pathway arm
Patients undergo same-day admission for intra-arterial treatment under local anaesthesia and are discharged on the same day based on a standardised study discharge assessment. Same-day discharge is authorised using predefined criteria, including haemodynamic stability, adequate pain control with oral medication, absence of uncontrolled nausea or vomiting, absence of clinically relevant access-site complications and final validation by the responsible clinician after review of peri-procedural assessments (clinical examination and safety laboratory parameters and imaging when indicated). Post-discharge monitoring combines structured nursing calls and scheduled laboratory surveillance. Nursing calls follow a standardised checklist and are performed the evening of the procedure, the day after the procedure and at 48 hours; they assess abdominal pain (analgesic intake and 0–10 numerical rating scale), nausea/vomiting, fever (maximum temperature and duration), treatment adherence and any other concerns and trigger predefined escalation to the interventional radiology team/on-call resident when needed. In addition, post-procedural blood tests required for safety follow-up are performed in the community at 24, 48 and 72 hours after TACE (48 hours only after TARE), and results are transmitted to the treating team to detect early hepatic dysfunction or inflammatory complications and to organise direct reassessment or direct readmission when indicated. If a participant randomised to the ambulatory arm requires an overnight stay because discharge criteria are not met (delayed discharge or unplanned admission), they will remain analysed in their assigned group under the modified intention-to-treat approach, and the event will be reported as an ambulatory pathway failure.
Conventional inpatient care arm
Standard inpatient hospitalisation for 24–72 hours post-procedure according to current centre practice.
Intervention adherence and modification
Although adherence is naturally high in procedural oncology trials, intervention fidelity will be monitored through electronic case report form (eCRF) documentation. Discontinuation or modification of allocated care pathways may occur in case of clinical deterioration or logistical constraints and will be recorded with detailed justification.
Follow-up schedule
Patients are followed for up to 7 months. The schedule includes a baseline assessment within 30 days before the procedure, the treatment day (day 0), a satisfaction assessment at 72 hours and a telephone follow-up at day 7. On-site visits are planned at 2 months for TACE or 3 months for TARE and again at 6 months. In addition, qualitative interviews will be conducted with a subset of 30 patients, both pre- and post-procedure.
Outcomes
Primary outcome
The primary outcome is the global satisfaction score from the EORTC PATSAT-C33 questionnaire, assessed 3 days post-procedure.15 The PATSAT-C33 is self-administered: participants complete it independently, without assistance from clinical staff and it is not administered by treating clinicians or members of the ambulatory care team.
Day 3 was selected because it corresponds to completion of the early post-procedural care pathway and captures the period during which the key organisational components of the ambulatory strategy are delivered, including structured nursing calls and protocolised safety monitoring. Post-embolisation syndrome after TACE is an early clinical syndrome that typically manifests within the first 1–3 days5 16; day 3 therefore reflects both early symptom burden and its management, which are central to patient experience and perceived safety. This primary time point was chosen to assess the immediate experience of care organisation and support after TACE or TARE rather than later disease-related outcomes. Events occurring beyond 72 hours, including unplanned healthcare use and readmissions, are captured as secondary outcomes during follow-up.
Secondary outcomes
Secondary outcomes include comfort and satisfaction assessed with the EORTC OUT-PATSAT7 module, quality of life measured with the SF-12, anxiety and depression assessed with the Hospital Anxiety and Depression Scale (HADS) and ECOG performance status. They also include technical success and tumour response evaluated using mRECIST and LI-RADS, adverse events graded according to CTCAE V.5.0, implementation metrics (acceptability, adoption, feasibility, relevance, reach and sustainability) and cost and budget impact analyses. Ambulatory pathway failure will be defined as any of the following events: an unplanned hospital admission after the procedure (including same-day unplanned admission), delayed discharge when the planned same-day discharge cannot be achieved because predefined discharge criteria are not met or hospital readmission within the predefined early post-procedural window (72 hours). These events will be reported explicitly as safety and pathway-performance outcomes. The complete pre-specified list of secondary outcomes, with their measures and time points, is provided in online supplemental material 3 and corresponds to the trial registry (NCT06990659).
Sample size
No published data currently allow estimation of the expected difference in patient satisfaction between ambulatory and conventional inpatient care pathways for intra-arterial therapies in primary liver cancer when measured using the EORTC PATSAT-C33. The EORTC PATSAT-C33 is a validated questionnaire designed to assess satisfaction with cancer care in both outpatient and inpatient settings.17 In the absence of prior evidence to inform a minimally important difference for this specific organisational comparison, we based the sample size on a standardised effect-size approach.18–20 We assumed a standardised mean difference (Cohen’s d) of 0.5, corresponding to a moderate effect size according to conventional benchmarks and considered that only a difference of at least moderate magnitude would justify implementation of a substantial pathway reorganisation.20 With a two-sided α of 0.05 and 90% power, detecting an effect size of 0.5 with a two-sample comparison of means requires 86 evaluable participants per group (172 total). We anticipated up to 20% missing data for the primary endpoint and therefore inflated the target sample size to 206 participants (103 per group); this threshold is commonly cited as a level at which missing outcome data may threaten trial validity if not appropriately addressed.21
Randomisation and blinding
Randomisation will be performed centrally via Ennov Clinical using variable block sizes and stratification factors (treatment type, centre experience). Participants will be allocated using a centralised, computer-generated sequence. Allocation concealment is ensured by the electronic system, which releases assignments only after full eligibility confirmation.
Blinding of patients and clinicians is not feasible due to the nature of the intervention (ambulatory vs inpatient). However, statisticians and outcome assessors will remain blinded to group allocation to minimise detection and analysis bias. No unblinding procedures are required given the pragmatic design.
Data collection and management
All clinical and patient-reported data are entered into a secure eCRF managed by the DRCI of CHU Angers. Data will be coded, with identification via centre and patient numbers. Qualitative interviews will be audio-recorded, anonymised and transcribed. Imaging data will be transferred in anonymised DICOM format via the ETIAM Nexus network. The data required for economic analysis will be extracted directly from the French national health data system (SNDS) and micro-costing data.
Data security, storage (15 years) and processing comply with GDPR and the French MR-001 framework.
Statistical analysis
Analyses will follow the modified intention-to-treat principle. Continuous variables will be summarised as mean±SD or median (IQR); categorical variables as counts (%).
Primary analysis
The primary endpoint (EORTC PATSAT-C33 global satisfaction score at day 3) will be compared between groups using a regression model adjusted for the randomisation stratification factors (treatment type and centre experience and for the TARE stratum, the centre’s organisation for the preparatory angiography when applicable). To account for potential centre-specific cultural or organisational effects, the centre will be included in the model. To address expectation-related influences, a prespecified adjusted analysis will additionally include baseline covariates that may affect satisfaction reporting, including psychological status (HADS assessed at inclusion and pre-procedure) and key sociodemographic/clinical characteristics collected at baseline. A sensitivity analysis using multiple imputation will assess robustness to missing data.
Because the trial is open-label and the primary endpoint is patient-reported satisfaction, expectation bias cannot be fully excluded. Potential expectation-related influences will be explored and contextualised using the embedded qualitative component, which documents pre-intervention expectations and representations of ambulatory versus inpatient care (including prior experiences and counselling) and will support interpretation through triangulation with quantitative findings.
Secondary analyses
Secondary analyses will use mixed-effects models for repeated measures for quality of life, pain and anxiety; logistic regression for complications and predictors of success; Fine–Gray competing-risk models for progression and microcosting and generalised linear model (GLM)-based economic models. Prespecified subgroup analyses will explore whether the effect of the ambulatory pathway differs according to treatment modality (TACE vs TARE). This will be assessed by including a treatment-by-arm interaction term in the primary regression model and by reporting modality-specific effect estimates with 95% CIs. These analyses are exploratory because the trial was not powered to detect interaction effects or to provide definitive comparisons within each modality; therefore, results will be interpreted with appropriate caution. To characterise variability in usual care across centres, length of stay in the conventional inpatient arm will be reported by centre. In addition to modelling centre effects in the primary analysis, a set of centre-level organisational characteristics will be collected. These variables will include dedicated interventional oncology nursing resources, availability of structured post-discharge monitoring and a direct readmission pathway and prior experience with ambulatory TACE/TARE or related ambulatory endovascular procedures. Centre-level characteristics will be summarised descriptively and explored in prespecified exploratory analyses to assess whether organisational readiness modifies the effect of the ambulatory pathway.
Analyses will be conducted using Stata 14.2, with a significance threshold of 0.05.
Qualitative and implementation evaluation
An embedded qualitative study will explore patient and provider perspectives on ambulatory care.
Patient interviews
Approximately 30 patients will be invited to participate in semi-structured interviews conducted both before and after treatment. Participants will be recruited using purposive sampling to ensure diversity in age, sex, frailty, tumour type (HCC vs iCCA), treatment modality (TACE vs TARE) and prior experience with ambulatory pathways. Interviews will explore expectations, reassurance and information needs, perceived safety, autonomy, experience of symptoms and support after discharge and overall appraisal of the care pathway (online supplemental material 4): patient interview guide). Participants invited to the qualitative interviews will provide additional consent for audio recording and use of transcripts (online supplemental material 5).
Focus groups
Three focus groups involving professionals from participating centres. Participants will be purposively selected to capture heterogeneity in roles, seniority, exposure to ambulatory care pathways and variability in centre characteristics (size, organisational structure, maturity of ambulatory practice) (online supplemental material 4): focus group guide). Each focus group will bring together 8–10 participants (physicians, nurses, radiographers and administrative or coordination staff as applicable) and 2 members of the research team (one facilitator and one observer). Healthcare professionals participating in focus groups will provide written consent for audio/video recording and use of anonymised transcripts (online supplemental material 6).
Research team, gender, training, independence and reflexivity
Focus groups will be conducted by a team of three female nursing lecturers and researchers (registered nurses, PhD). Two are full-time researchers and will alternate as facilitators, and the third is an advanced practice nurse who will act as an observer during focus groups. Individual patient interviews will be conducted by a female PhD researcher in sociology who has never worked in the interventional radiology department and is independent from the clinical care teams. All four researchers have experience and training in qualitative interviewing and facilitation techniques. They have no professional connection with the healthcare professionals participating in the focus groups, and the interviewer conducting patient interviews has no prior relationship with the patients. One member of the team works as an advanced practice nurse in a hepatology department; because her prior experience with outpatient care could influence interactions with participants, she will not conduct patient interviews or facilitate focus groups. To support reflexivity and minimise interpretive bias, her preconceptions and assumptions regarding outpatient care will be documented in advance in a logbook shared with the qualitative team, and reflexive discussions will be held during analysis.
Analysis and integration with implementation outcomes
Interviews and focus groups will be audio-recorded with consent, transcribed verbatim and analysed using thematic analysis with a constant comparative approach. Coding will follow an inductive strategy and will be performed independently by three qualitative researchers (Université Paris Cité, ECEVE UMR 1123), with triangulation to enhance credibility and consistency.22 Coding will follow an inductive approach, with triangulation to enhance credibility and consistency. Implementation outcomes will be assessed according to conceptual frameworks by Curran et al and Peters et al,11 12 covering acceptability, adoption, feasibility, fidelity, reach and sustainability. Qualitative findings will be integrated with quantitative results to support interpretation, identify factors influencing satisfaction and pathway success and inform recommendations for wider dissemination. Particular attention will be paid to documenting and analysing pre-intervention expectations regarding outpatient versus inpatient follow-up among both patients and professionals, using the pre-treatment patient interviews and the professional focus groups.
Economic evaluation
Two complementary economic analyses will be conducted by the CHU Angers Health Economics Unit (UEME) in collaboration with the CHU Tours UEME, following the Health Economic Evaluation Checklist for France.
Cost-analysis
The trial-based cost analysis will adopt collective, hospital and French National Health Insurance perspectives. The time horizon corresponds to the second post-treatment visit (2 months after TACE and 3 months after TARE), and the primary economic endpoint is total cost per patient at that visit. Resource use and costs will be derived from the SNDS (hospital claims, reimbursed outpatient care, transports and sick leave), complemented by a microcosting approach for the ambulatory pathway to capture in-hospital resources and hospital staff time devoted to outpatient follow-up (including nursing calls and medical teleconsultations). Patient diary data will capture informal care and personal services. Costs will be analysed in intention-to-treat and per-protocol populations. Group differences will be estimated using non-parametric bootstrap methods, and sensitivity analyses will use GLM and/or multilevel models to explore cost drivers.
5-year budget impact analysis
The 5-year budget impact analysis will be conducted from the perspective of the French National Health Insurance. It will use an open-cohort model structure incorporating varied uptake scenarios for ambulatory versus inpatient pathways and will report annual and cumulative cost impacts across adoption scenarios. Both analyses will adhere to French methodological guidelines and incorporate deterministic and probabilistic sensitivity analyses.23 24
Ethics and regulatory considerations
The CHOC trial is classified as a minimal-risk interventional study under French law (Arrêté du 12 avril 2018). Ethical approval was obtained from a Protection of Persons Committee (Comité de protection des personnes Sud-Méditerranée V, SI number: 25.00983.000648, national number: 2024-A02727-40) and authorisation for data handling has been requested from the National Commission of Information Technology and Freedoms (CNIL) for linkage with the French national health data system (SNDS). The sponsor (CHU Angers) provides liability insurance (Relyens contract no 164359). For the qualitative component, additional consent will be obtained for audio recordings and use of interview transcripts.
Patient and public involvement
Patients were not directly involved in the design phase of this study. However, their perspectives were explored during a national survey of interventional radiology practices in 2022, which informed the feasibility assessment and identified patient-centred priorities (comfort, autonomy, safety). Future dissemination will include summaries for patients and participating centres. Results of this study will be shared through accessible summaries to participants and participating centres.
Dissemination
Results will be disseminated through peer-reviewed open-access journals, national and international conferences, scientific and professional societies and direct feedback to participating centres to support implementation. Although the organisational and economic evaluations are conducted in France, key pathway components (patient selection, standardised discharge criteria, early safety monitoring with structured follow-up and escalation rules and direct access/readmission procedures) are expected to be transferable, while cost results can be re-parameterised using local unit costs. A lay summary and a visual abstract will be made available through institutional websites. Results will be disseminated through peer-reviewed open-access journals, national and international conferences, scientific and professional societies and direct feedback to participating centres to support implementation. A lay summary and a visual abstract will be made available through institutional websites.
Supplementary material
Acknowledgements
The authors would like to thank Marie Bost and Anaïs Boyron, clinical research coordinators at CHU Angers, for their essential role in coordinating the study across centres. The authors also acknowledge the support of the Délégation à la Recherche Clinique et à l’Innovation (DRCI) of Angers, including Sandra Merzeau, Béatrice Gable and Elsa Parot-Shinkel, for their valuable contributions to study setup, monitoring and regulatory oversight.
Footnotes
Funding: This study is funded by the French Ministry of Health through the Programme de recherche sur la performance du système de soins (PREPS-22-0065), operated by the Direction générale de l’offre de soins (DGOS). Sponsored by CHU Angers (DRCI).
Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2025-114720).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.
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