Hepato Cellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma
Conditions
Keywords
ambulatory care, hospitalization, Hepato cellular carcinoma, Patient satisfaction, randomized trial, chemoembolization, radioembolization, Intrahepatic, Cholangiocarcinoma, Primary liver cancer
Brief summary
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
OTHERAmbulatory 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.
OTHERConventional 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.
Sponsors
University Hospital, Angers
Université Paris Cité
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall patient satisfaction | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability (quantitative) | At inclusion visit (pre-treatment) | Proportion of consenting patients and description of refusals |
| Acceptability (qualitative) | At inclusion visit (pre-treatment) | Thematic analysis of individual research interviews with a sample of patients included in both arms of the study. |
| Adoption (quantitative) | 32 months | Number of outpatient courses completed compared with the number of scheduled courses; number of candidate, open and active centers. |
| Adoption (qualitative) | 36 months | Thematic analysis of verbatims collected during focus groups with centers |
| Relevance (reasons for refusal) | 24 months | Characteristics of patients whose inclusion in the protocol was refused by the patient/carer. |
| Relevance (patient expectations) | 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. |
| Feasibility of outpatient care | 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. |
| Reach (Quantitative) | One year after the end of inclusions | Patient-related factors associated with ambulatory care pathway failure (Indication; Techniques; Tolerance of organization). |
| Reach (Qualitative for centers) | 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 |
| Reach (Qualitative for patients) | 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 |
| Comparing the organizations (Pain) | 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') |
| Comparing the organizations (Comfort and satisfaction) | 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) |
| Comparing the organizations (Quality of life) | 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 |
| Comparing the organizations (General condition) | 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) |
| Comparing the organizations (Complications) | Month 6 | Complications according to the Common Terminology Criteria for Adverse Events (CTCAE) V5.0.5 Items from 1 (mild) to 5 (death) |
| Comparing the organizations (Technical succes) | 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) |
| Factors for patient satisfaction (HADS) | Inclusion, Admission before surgery and 72 hours after procedure | Anxiety and depression scale (HADS) |
| Factors for patient satisfaction (Disease characteristics) | At inclusion visit (pre-treatment) | Barcelona Clinic Liver Cancer (BCLC) classification stage, sarcopenia (based on imaging). |
| Factors for patient satisfaction (Treatment characteristics) | Day of treatment procedure | 1. for transarterial chemoembolization (TACE) : selectivity, number of segments treated, % of chemotherapy injected, additional embolization; 2. for transarterial radioembolization (TARE): number of injection sites; 3. for all: procedure duration, center volume, operator volume, treatment line, combination treatment. |
| Factors for patient satisfaction (socioeconomic) | At inclusion visit (pre-treatment) | Socioeconomic level |
| Factors for patient satisfaction (travel) | At inclusion visit (pre-treatment) | Home-hospital travel time |
| Factors for patient satisfaction (comorbidities) | At inclusion visit (pre-treatment) | Comorbidities |
| Factors for patient satisfaction (ECOG) | At inclusion visit (pre-treatment) | Clinical status (ECOG) |
| Factors for patient satisfaction (Quality of life) | At inclusion visit (pre-treatment), Day 7, Month 2/Month3 | Questionnary of quality of life = Medical Outcome Study Short Form 12 (SF-12) |
| Total cost of each treatment pathway | 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) |
| Budgetary impact | 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 |
| Ambulatory pathway failure | 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) |
Countries
France
Contacts
CONTACTChristophe AUBE, Pr
CONTACTSandra MERZEAU
PRINCIPAL_INVESTIGATORChristophe AUBE, Pr
University Hospital, Angers
PRINCIPAL_INVESTIGATORJules GREGORY, Assoc Pr
Beaujon Hospital (APHP) - Paris cité University
Outcome results
None listed