Outpatient Care Pathway for Patients Treated Intra-arterially for Primary Liver Cancer (CHOC)

University Hospital, Angers

Status: Not yet enrolling

Conditions: Hepato Cellular Carcinoma (HCC)

Treatments: Other: Ambulatory care; Other: Conventional inpatient care

Study type: Interventional

Funder types: Other

Identifiers

NCT06990659

49RC23_0306

2024-A02727-40 (Other Identifier)

Details and patient eligibility

About

Randomized trial comparing two care organizations (outpatient versus conventional inpatient care) using a mixed method (quantitative and qualitative data and analysis).

The protocol involves randomization between an ambulatory group and a conventional hospitalization group. Patients will be monitored for 7 months to assess satisfaction, complications and treatment efficacy. A qualitative study will be carried out to understand the obstacles and facilitate implementation of the ambulatory pathway. A medico-economic analysis will accompany this study to assess the financial impact of adopting the ambulatory pathway. The expected results will help determine the best management strategy for these patients.

The study's hypotheses are that performing intra-arterial treatments for primary liver cancer on an outpatient basis, combined with telephone follow-up, will improve patient satisfaction with their care, and that analysis of the implementation of this outpatient pathway will help improve the pathway and facilitate its implementation at other sites, by identifying obstacles and solutions.

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• HCC or CCi diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven.
• HCC or CCi naive to intra-arterial treatment. HCC 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 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 CCi)
• 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
• Chronic renal insufficiency (Clairance < 30 ml/min)
• Known allergy to a contrast agent or chemotherapy agent
• Patient unable to be a candidate for outpatient management
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Arm Ambulatory care

Experimental group

Description:

Ambulatory care : Outpatient management of radiological treatment for HCC

Treatment:

Other: Ambulatory care

Arm Conventional inpatient care

Other group

Description:

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

Treatment:

Other: Conventional inpatient care