The event took place on 10 November 2023 in Boston, MA, USA, on the occasion of The Liver Meeting 2023 – the annual meeting of the American Association for the Study of Liver Diseases (AASLD).
Regional Coordinators for North America Ruben Hernaez (Michael E. DeBakey Veterans Affairs Medical Center, TX, USA) and Constantine Karvellas (University of Alberta, Canada) co-chaired the event.
Rajiv Jalan (Scientific Coordinator of the CHANCE study at University College London – Royal Free Hospital, UK), welcomed attendees and briefly reviewed the rationale behind the CHANCE study. He highlighted the work by former Regional Coordinator for North America Vinay Sundaram (Cedars-Sinai Medical Center, CA, USA), who sadly passed away last year, for contributing to define the main questions that CHANCE aims to answer. Next, Jalan presented results from the interim analysis carried out by statisticians at the EF CLIF Data Management Center and explained why patient recruitment to current protocol could stop after having enrolled more than 1000 patients in the study.
William Bernal (Co-Principal Investigator at King’s College London, UK) shared his insights about the future of the CHANCE study and challenges that need to be overcome for the success of the project. He pointed out that recruitment of patients with severe acute-on-chronic liver failure (ACLF) (i.e., patients included in group 1) will continue to be able to define liver transplant futility criteria and develop a new prognostic model for transplant candidate selection.
Cristina Sánchez-Garrido (Head of the Data Management Center at EF CLIF, Spain) stressed that data quality and completeness is essential to address both primary and secondary objectives, and described the route to achieving them through changes in the electronic case report form that will be available during phase 2 of the study.
Jalan presented a plan for publications, reviewed authorship based on previous agreements and provided an outline of the process to apply for ancillary studies. He introduced the LEOPARD project – Liver electronic offering platform with artificial intelligence-based devices – coordinated by Assistance Publique–Hôpitaux de Paris (AP–HP) as an example of successful ancillary study that has recently received funding from the European Union within the framework of the Horizon Europe research and innovation program.
Co-chairs of the meeting moderated a final Q&A session and closed the meeting.
The CHANCE study is promoted by European Foundation for the Study of Chronic Liver Failure.
About the CHANCE study
CHANCE is a multicenter, global, observational study designed to assess the benefit of liver transplantation in patients with acute-on-chronic liver failure (ACLF) grade 2 or grade 3. This study counts with the support of the International Liver Transplantation Society (ILTS) and the European Liver and Intestine Transplant Association (ELITA) to recruit 2000 patients in 80 centers in 27 countries around the world. The primary objective of the CHANCE study is to compare 1-year graft and patient survival rates after liver transplantation in patients with ACLF grade 2 or grade 3 at the time of liver transplantation with patients with decompensation of cirrhosis without ACLF-2 or 3 and transplant-free survival of patients with ACLF-2 or 3 not listed for liver transplantation. The international nature of this study will allow for deep assessments of the potential impact of different precipitating factors of ACLF (e.g., alcohol vs. Hepatitis B virus flare), different types of liver transplantation (deceased donor vs. living donor liver transplantation) and different regional and national allocation systems on transplant outcomes. Beside these clinical objectives, the CHANCE study aims to build a repository of biological samples to explore new biomarkers to predict prognosis on the waiting list and after liver transplantation, and mechanisms of liver and extrahepatic organ recovery.
ClinicalTrials.gov Identifier: NCT04613921