Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06990659

Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer: Randomized Multicenter Trial

Led by University Hospital, Angers · Updated on 2026-03-11

206

Participants Needed

14

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Angers

Lead Sponsor

U

Université Paris Cité

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing two ways of caring for patients with primary liver cancer, specifically Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA), who undergo treatments called transarterial chemoembolization (TACE) or radioembolization (TARE). This randomized multicenter trial aims to assess patient satisfaction, safety, and clinical outcomes over a follow-up period of 7 months. The study also includes a qualitative implementation assessment and an economic evaluation to understand how acceptable, feasible, and sustainable outpatient care is compared to conventional inpatient care. The trial has two groups: one where patients receive ambulatory care, meaning they are treated as outpatients with follow-up phone calls and nursing support for 48 to 72 hours after treatment depending on the procedure, and another where patients receive conventional inpatient care with traditional hospitalization during treatment. If complications arise in the outpatient group, a special re-hospitalization plan is in place. These care pathways are compared for comfort, satisfaction, quality of life, complications, and costs. Participants will be evaluated before treatment and monitored through various visits up to 7 months after the procedure. Assessments include patient satisfaction within 72 hours post-treatment, quality of life, general condition, technical success of treatment, and any complications. The study also records economic data and long-term budget impact. Patients' adherence and safety are monitored, and outcome measures include both quantitative and qualitative evaluations to thoroughly compare outpatient and inpatient care models in this patient population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) based on European Association for the Study of the Liver criteria or histology
  • No prior intra-arterial treatment for HCC or iCCA
  • If treatment proposed at Multidisciplinary Consultation Meeting (RCP): Child-Pugh score less than B8, single or multiple HCC, no lobar or truncal portal obstruction, no bile duct dilation
  • For radioembolization treatment proposal: no truncal portal tumor invasion, uni-lobar tumor invasion (except centrohepatic iCCA), total bilirubin less than 20 mg/l (or 35 µmol/L)
  • Affiliated with or benefiting from a social security scheme
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Technical contraindication or predictable technical difficulty
  • Planned combined same-day therapies at the procedure (e.g., TACE with percutaneous ablation)
  • Chronic renal insufficiency with clearance less than 30 ml/min
  • Known allergy to contrast or chemotherapy agents
  • Inability to participate in outpatient care (lack of understanding, no reliable phone, no responsible adult for first night, or no timely urgent care access)
  • Previously included in this study
  • Psychological, social, family, or geographical reasons preventing regular monitoring
  • Severe uncontrolled clinical diseases or infections
  • Pregnant, breastfeeding, or just given birth
  • Person deprived of liberty by judicial or administrative decision
  • Under compulsory psychiatric care
  • Under legal protection measures
  • Unable to give consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 72 hours post-procedure

Participants receive intra-arterial treatment for primary liver cancer either through outpatient ambulatory care with follow-up phone and nursing support for 48 to 72 hours or through conventional inpatient hospitalization.

1 treatment visit followed by telephone and on-demand nursing follow-up within 48 to 72 hours

Follow-up

Duration - Up to 6 months

Participants are monitored for outcomes such as patient satisfaction, quality of life, complications, and treatment success up to 6 months after treatment.

Visits at Day 7, Month 2/3, and Month 6

Trial Site Locations

Total: 14 locations

1

University hospital of Amiens

Amiens, France, 80054

Not Yet Recruiting

2

University hospital of Angers

Angers, France, 49933

Actively Recruiting

3

University hospital of Besançon

Besançon, France, 25030

Actively Recruiting

4

Hospital of Avicennes (AP-HP)

Bobigny, France

Not Yet Recruiting

5

University hospital of Brest

Brest, France, 29609

Not Yet Recruiting

6

Hospital of Beaujon (AP-HP)

Clichy, France, 92110

Actively Recruiting

7

Hospital of Vendée

La Roche-sur-Yon, France, 85925

Actively Recruiting

8

University hospital of Grenoble-Alpes

La Tronche, France, 38700

Not Yet Recruiting

9

University hospital of Montpellier

Montpellier, France, 34090

Not Yet Recruiting

10

University hospital of Nice

Nice, France, 06202

Actively Recruiting

11

Hospital of Pitié-Salpétrière (AP-HP)

Paris, France, 75013

Actively Recruiting

12

Hospital of Cochin (AP-HP)

Paris, France, 75014

Actively Recruiting

13

Univesity hospital of Bordeaux

Pessac, France, 33607

Not Yet Recruiting

14

Institut Gustave Roussy (IGR)

Villejuif, France, 94805

Actively Recruiting

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Research Team

C

Christophe AUBE, Pr

S

Sandra MERZEAU

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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