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Publications

Journal Article Clinical Trial Protocol Epublish

PubMed: 42562579 DOI: 10.1136/bmjopen-2025-114720

Implementation and evaluation of an ambulatory care pathway for intra-arterial treatment of primary liver cancer: study protocol for a multicentre randomised controlled hybrid type 1 trial (CHOC).

BMJ Open 16(8):e114720

Authors: Jules Grégory, Jean-François Hammel, Maxime Ronot, Charles Roux, Maxime Barat, Manon Allaire, Lucia Parlati, Nadia Moussa, Paul Beunon, Frédéric Oberti, Patrick Chevallier, Rodolphe Anty, Paul Girot, Olivier Sutter, Nathalie Ganne, Panteleimon Papadopoulos, Jean-Frédéric Blanc, Julien Ghelfi, Thomas Decaens, Thierry Yzet, Eric Nguyen-Khac, Benoît Magnin, Léon Muti, Jean-Romain Risson, Florence Tann, Valérie Boige, Paul Calame, Carine Richou, Valérie Vilgrain, Pierre-Emmanuel Rautou, Astrid Darsonval, Rita Nhora, Julie Devictor, Mohamed Bouattour, Emmanuelle Cartron, Christophe Aubé

Affiliations

  • Department of Radiology, CRI Inserm 1149, Université Paris Cité, FHU MOSAIC², AP-HP Hôpital Beaujon, Clichy, France.
  • Département de Biostatistique, CHU Angers, Angers, France.
  • Department of Radiology, CRI Inserm 1149, Université Paris Cité, FHU MOSAIC², AP-HP Hôpital Beaujon, Clichy, France.
  • Department of Interventional Radiology, AP-HP Hôpital Pitié-Salpêtrière, Paris, France.
  • Department of Radiology, AP-HP Hôpital Cochin, Paris, France.
  • Department of Hepatology, AP-HP Hôpital Pitié-Salpêtrière, Paris, France.
  • Department of Hepatology, AP-HP Hôpital Cochin, Paris, France.
  • Department of Radiology, CHD Vendée, La Roche-sur-Yon, France.
  • Department of Interventional Radiology, Institut Gustave-Roussy, Villejuif, France.
  • Department of Hepatology, CHU Angers, Angers, France.
  • Department of Radiology, CHU Nice, Nice, France.
  • Department of Hepatology, CHU Nice, Nice, France.
  • Department of Hepatology, CHD Vendée, La Roche-sur-Yon, France.
  • Department of Interventional Radiology, AP-HP CHU Avicenne, Bobigny, France.
  • Department of Hepatology, AP-HP CHU Avicenne, Bobigny, France.
  • Department of Digestive and Interventional Imaging, CHU Bordeaux, Pessac, France.
  • Department of Hepatology, CHU Bordeaux, Talence, France.
  • Department of Radiology, CHU Grenoble Alpes, La Tronche, France.
  • Department of Hepatology, CHU Grenoble Alpes, Grenoble, France.
  • Department of Radiology, CHU Amiens, Amiens, France.
  • Department of Hepatology, CHU Amiens, Amiens, France.
  • Department of Radiology, CHU Clermont-Ferrand, Clermont-Ferrand, France.
  • Department of Digestive and Hepatobiliary Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France.
  • Department of Radiology, CHU Brest, Brest, France.
  • Department of Hepatology, CHU Brest, Brest, France.
  • Department of Oncology, Institut Gustave-Roussy, Villejuif, France.
  • Department of Radiology, CHU Besançon, Besançon, France.
  • Department of Hepatology, CHU Besançon, Besançon, France.
  • Department of Hepatology, AP-HP Hôpital Beaujon, Clichy, France.
  • Department of Pharmacy, Angers University Hospital, Angers, France.
  • Université Paris Cité, ECEVE, INSERM UMR 1123, Paris, France.
  • Liver Cancer and Innovative Therapy Unit, AP-HP Hôpital Beaujon, Clichy, France.
  • CHU Angers, Department of Radiology, Laboratoire HIFIH UPRES 3859, SFR ICAT 4208, Angers University, Angers, France.

Abstract

INTRODUCTION

Primary liver cancers, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, are one of the leading causes of cancer-related mortality. Transarterial chemoembolisation (TACE) and radioembolisation (TARE) are established palliative treatments yet they are traditionally performed during inpatient hospitalisation. Recent technical and organisational advances allow for safe same-day ambulatory procedures. In particular, the extent to which ambulatory intra-arterial therapy aligns with patients' expectations, comfort and quality of life remains poorly documented. The Care pathway for Hepatic intra-arterial Oncology in an ambulatory Context study (CHOC) trial aims to evaluate the implementation and effectiveness from both patient-centred and clinical perspectives of an ambulatory care pathway for intra-arterial treatment of primary liver cancer in a multicentre randomised hybrid type 1 trial.

METHODS AND ANALYSIS

CHOC is a pragmatic, multicentre, randomised controlled hybrid type 1 trial comparing ambulatory versus conventional inpatient care for patients undergoing TACE or TARE for primary liver cancer. A total of 206 patients (103 per arm) will be randomised 1:1 and followed for 7 months. The primary outcome is the patient's global satisfaction score, measured 3 days post-procedure using the EORTC PATSAT-C33 questionnaire. Secondary outcomes include quality of life, safety, clinical outcomes, cost analysis and an embedded qualitative implementation study assessing acceptability, adoption, feasibility and sustainability across centres. Economic analyses will estimate both per-patient costs and the 5-year budget impact for the French national health insurance.

ETHICS AND DISSEMINATION

The study has received ethical approval from the Protection of Persons Committee and adheres to the Declaration of Helsinki, good clinical practice and French regulatory requirements. Findings will be disseminated through peer-reviewed publications, conferences and participating centres to guide broader implementation of ambulatory interventional radiology care.

TRIAL REGISTRATION NUMBER

NCT06990659.

MeSH

Quality Of Life, Neoplasms, Liver, Liver Neoplasms, Ambulatory Care, Therapeutics