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

March 9, 2026 updated by: University Hospital, Angers

CHOC - 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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • University Hospital of Amiens
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thierry YZET, Pr
      • Angers, France, 49933
        • Recruiting
        • University Hospital of Angers
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christophe AUBE, Pr
      • Besançon, France, 25030
        • Recruiting
        • University Hospital of Besancon
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul CALAME, Dr
      • Bobigny, France
        • Not yet recruiting
        • Hospital of Avicennes (AP-HP)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olivier SUTTER, Dr
      • Brest, France, 29609
        • Not yet recruiting
        • University Hospital of Brest
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Romain RISSON, Dr
      • Clichy, France, 92110
        • Recruiting
        • Hospital of Beaujon (AP-HP)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jules GREGORY, Dr
      • La Roche-sur-Yon, France, 85925
        • Recruiting
        • Hospital of Vendée
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nadia MOUSSA, Dr
      • La Tronche, France, 38700
        • Not yet recruiting
        • University hospital of Grenoble-Alpes
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julien GHELFI, Dr
      • Montpellier, France, 34090
        • Not yet recruiting
        • University Hospital of Montpellier
        • Principal Investigator:
          • Boris GUIU, Pr
        • Contact:
        • Contact:
      • Nice, France, 06202
        • Recruiting
        • University Hospital of Nice
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick CHEVALLIER, Dr
      • Paris, France, 75013
        • Recruiting
        • Hospital of Pitié-Salpétrière (AP-HP)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles ROUX, Dr
      • Paris, France, 75014
        • Recruiting
        • Hospital of Cochin (AP-HP)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maxime BARAT, Pr
      • Pessac, France, 33607
      • Villejuif, France, 94805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • HCC or iCCA naive to intra-arterial treatment. HCC or iCCA may have been previously treated with other non-intra-arterial therapies. Other HCC may have been previously treated but not with intra-arterial therapy.
  • If HCC ou iCCA treatment is proposed at a Multidisciplinary Consultation Meeting (RCP):
  • Patient Child-Pugh < B8
  • Single or multiple HCC
  • Absence of lobar or truncal portal obstruction
  • Absence of bile duct dilatation
  • If treatment by REH 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm Ambulatory care
Ambulatory care : Outpatient management of radiological treatment for HCC and iCCA
Other: Ambulatory care
Patients with Hepato cellular carcinoma (HCC) and Intrahepatic cholangiocarcinoma (iCCA) treated by chemo-embolization (CEH) or radioembolization (REH) 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 REH and 72 hours for CEH. A dedicated re-hospitalization circuit has also been set up in the event of complications.
Other: Arm Conventional inpatient care
Conventional inpatient care : Conventional inpatient management for radiological treatment of HCC and iCCA
Other: Conventional inpatient care
Patients with Hepato cellular carcinoma (HCC) and Intrahepatic cholangiocarcinoma treated by chemo-embolization (CEH) or radioembolization (REH) are managed on an inpatient basis: conventional hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours after treatment procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability (quantitative)
Time Frame: At inclusion visit (pre-treatment)
Proportion of consenting patients and description of refusals
At inclusion visit (pre-treatment)
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.
At inclusion visit (pre-treatment)
Adoption (qualitative)
Time Frame: 36 months
Thematic analysis of verbatims collected during focus groups with centers
36 months
Relevance (reasons for refusal)
Time Frame: 24 months
Characteristics of patients whose inclusion in the protocol was refused by the patient/carer.
24 months
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.
36 months
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.
One year after the end of inclusions
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
At inclusion visit (pre-treatment), Day 7, Month2/Month3 visit
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)
At inclusion visit (pre-treatment), Month2/Month3 visit
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)
Month 6
Comparing the organizations (Technical succes)
Time Frame: Month2/Month3 visit, Month 6
Technical success defined by completion of the planned procedure. Tumor response according to Response Evaluation Criteria in Solid Tumors (mRECIST) and Liver Imaging Reporting and Data System (LIRADS)
Month2/Month3 visit, Month 6
Factors for patient satisfaction (Disease characteristics)
Time Frame: At inclusion visit (pre-treatment)
Barcelona Clinic Liver Cancer (BCLC) classification stage, sarcopenia (based on imaging).
At inclusion visit (pre-treatment)
Factors for patient satisfaction (Treatment characteristics)
Time Frame: Day of treatment procedure
  1. for hepatic chemoembolization (CEH): selectivity, number of segments treated, % of chemotherapy injected, additional embolization;
  2. for radioembolization (REH): number of injection sites;
  3. for all: procedure duration, center volume, operator volume, treatment line, combination treatment.
Day of treatment procedure
Factors for patient satisfaction (socioeconomic)
Time Frame: At inclusion visit (pre-treatment)
Socioeconomic level
At inclusion visit (pre-treatment)
Factors for patient satisfaction (travel)
Time Frame: At inclusion visit (pre-treatment)
Home-hospital travel time
At inclusion visit (pre-treatment)
Factors for patient satisfaction (comorbidities)
Time Frame: At inclusion visit (pre-treatment)
Comorbidities
At inclusion visit (pre-treatment)
Factors for patient satisfaction (ECOG)
Time Frame: At inclusion visit (pre-treatment)
Clinical status (ECOG)
At inclusion visit (pre-treatment)
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)
At inclusion visit (pre-treatment), Day 7, Month 2/Month3
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)
From day of treatment to Month 2/Month 3 visit
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
5 years after study
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.
32 months
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).
One year after the end of inclusions
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
One year after the end of inclusions
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
One year after the end of inclusions
Comparing the organizations (Comfort and satisfaction)
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')
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

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)
72 hours after procedure
Factors for patient satisfaction (HADS)
Time Frame: Inclusion, Admission before surgery and 72 hours after procedure
Anxiety and depression scale (HADS)
Inclusion, Admission before surgery and 72 hours after procedure
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)
within 72 hours post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

Université Paris Cité

Investigators

  • Principal Investigator: Christophe AUBE, Pr, University Hospital, Angers
  • Principal Investigator: Jules GREGORY, Assoc Pr, Beaujon Hospital (APHP) - Paris cité University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

December 17, 2027

Study Completion (Estimated)

December 17, 2028

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

May 21, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC23_0306
  • 2024-A02727-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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