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

NCT06990659 | Recruiting

• 2 other identifiers: 49RC23_03062024-A02727-40
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 14

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.

Conditions

Hepato Cellular Carcinoma (HCC); Intrahepatic Cholangiocarcinoma

Keywords

ambulatory care; hospitalization; Hepato cellular carcinoma; Patient satisfaction; randomized trial; chemoembolization; radioembolization; Intrahepatic; Cholangiocarcinoma; Primary liver cancer

Outcome Measures

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.

  72 hours after treatment procedure

Secondary Outcomes (27)

• Acceptability (quantitative)

  At inclusion visit (pre-treatment)

• Acceptability (qualitative)

  At inclusion visit (pre-treatment)

• Adoption (quantitative)

  32 months

• Adoption (qualitative)

  36 months

• Relevance (reasons for refusal)

  24 months

Study Arms (2)

Arm Ambulatory care

EXPERIMENTAL

Ambulatory care : Outpatient management of radiological treatment for HCC and iCCA

Other: Ambulatory care

Arm Conventional inpatient care

OTHER

Conventional inpatient care : Conventional inpatient management for radiological treatment of HCC and iCCA

Other: Conventional inpatient care

Interventions

Ambulatory care OTHER

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.

Arm Ambulatory care

Conventional inpatient care OTHER

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.

Arm Conventional inpatient care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• Université Paris Cité: collaborator

Study Sites (14)

University hospital of Amiens

Amiens, 80054, France

NOT YET RECRUITING

University hospital of Angers

Angers, 49933, France

RECRUITING

University hospital of Besançon

Besançon, 25030, France

RECRUITING

Hospital of Avicennes (AP-HP)

Bobigny, France

NOT YET RECRUITING

University hospital of Brest

Brest, 29609, France

NOT YET RECRUITING

Hospital of Beaujon (AP-HP)

Clichy, 92110, France

RECRUITING

Hospital of Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

University hospital of Grenoble-Alpes

La Tronche, 38700, France

NOT YET RECRUITING

University hospital of Montpellier

Montpellier, 34090, France

NOT YET RECRUITING

University hospital of Nice

Nice, 06202, France

RECRUITING

Hospital of Pitié-Salpétrière (AP-HP)

Paris, 75013, France

RECRUITING

Hospital of Cochin (AP-HP)

Paris, 75014, France

RECRUITING

Univesity hospital of Bordeaux

Pessac, 33607, France

NOT YET RECRUITING

Institut Gustave Roussy (IGR)

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Patient Satisfaction; Carcinoma, Hepatocellular

Interventions

Ambulatory Care

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Treatment Adherence and Compliance; Health Behavior; Behavior; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christophe AUBE, Pr

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• Jules GREGORY, Assoc Pr

  Beaujon Hospital (APHP) - Paris cité University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe AUBE, Pr

CONTACT

+33(0)24-135-4281; ChAube@chu-angers.fr

Sandra MERZEAU

CONTACT

+33(0)24-135-5970; SaMerzeau@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 25, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): December 17, 2028
• Last Updated: March 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)