Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ambulatory care
Other interventionPatients 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 interventionPatients 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.
Treatment groups
206 Participants
are divided into 2 treatment groupsGroup A: Arm Ambulatory careExperimental treatment 1 intervention
Group B: Arm Conventional inpatient careOther 1 intervention
Trial outcomes
Primary outcomes
1
Overall patient satisfaction
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.
Time frame
72 hours after treatment procedureSecondary outcomes
1
Acceptability (quantitative)
Proportion of consenting patients and description of refusals
Time frame
At inclusion visit (pre-treatment)2
Acceptability (qualitative)
Thematic analysis of individual research interviews with a sample of patients included in both arms of the study.
Time frame
At inclusion visit (pre-treatment)3
Adoption (quantitative)
Number of outpatient courses completed compared with the number of scheduled courses; number of candidate, open and active centers.
Time frame
32 months4
Adoption (qualitative)
Thematic analysis of verbatims collected during focus groups with centers
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Angers
Lead sponsor
Université Paris Cité
Collaborator
Source ClinicalTrials.gov