BARCELONA—On 17 November 2022, our collaborators at Hospital das Clínicas da Universidade de São Paulo in Brazil recruited patient no. 500. Provided sufficient data, this will allow us to conduct an interim assessment and guide future directions in the study.
The team at Hospital das Clínicas. From left to right: Flair Jose Carrilho, Alberto Farias, Patrícia Momoyo Zitelli, Luiz Marcelo Malbouisson, and Luiz Augusto Carneiro de Albuquerque. Picture: © Alberto Farias.
Prof. Dr. Alberto Farias, hepatologist and gastroenterologist at Hospital das Clínicas da Universidade de São Paulo has more than 30 years of experience in the treatment of liver and gastrointestinal disease. Thanks to the continued effort of Farias and his team, Hospital das Clínicas da Universidade de São Paulo has held the top position in the patient recruitment dashboard since February 2022.
Farias was co-principal investigator in the ACLARA study, our first investigation in Latin America that has helped us gain a broader perspective on the epidemiology and pathophysiology of acute-on-chronic liver failure (ACLF).
How did your center respond to the call for participating in the CHANCE study?
We really appreciated the invitation to participate in a global, ambitious and large-scale study that will define the role of liver transplantation for ACLF. We were aware of the challenges, complexity of the study and the need to improve our ability to communicate with different sectors of our hospital in order to be a competitive center. However, we believed we were able to collaborate with the global effort because our hospital is the largest healthcare center in Latin America and is the most active liver transplantation center in Brazil. Hospital das Clínicas is a population broad-based referral center in São Paulo city, with 2500 beds and has a specialized intensive care unit for digestive diseases, which would make possible the recruitment of patients for the study.
What are your motivations to participate in the CHANCE study?
Our hospital has a long tradition in liver transplantation, having performed the first deceased donor liver transplantation in 1968 and living donor liver transplantation in 1988. Although a significant number of liver transplants are annually performed in our unit and in Brazil, patients with advanced-grade ACLF are not granted priority for liver transplantation beyond MELD (model for end-stage liver disease) and mortality is high. We want to contribute to changing this reality.
What are the challenges, if any, in recruiting patients in your center and how it compares to other centers in your region?
The first challenge was to motivate people, organize the logistics of recruitment and be able to act on an around the clock schedule for collecting samples, including nights and weekends. The number of visits and the complexity of collecting and processing a large number of different samples sometimes is time-consuming and exhausting for a team with a limited number of persons.
Brazil is the fifth most populous country in the world, with marked regional differences in demographic and socioeconomic indexes and in access to health care provision. The Southeast covers 11% of the land mass but accounts for 43% of the population and 56% of the Brazilian gross domestic product (GDP). In contrast, the North region, which contains most of the Amazon rainforest, is spread over 45% of Brazil's land mass and contains only 8% of the population. These national disparities have a great impact on liver transplant activity. In this respect, the Southeast (where Hospital das Clínicas is located) and South regions generally have higher donation rates and better organ procurement because of increased public education and awareness as well a higher availability of resources. Access to liver transplantation is also easier because most of the liver transplant centers are distributed in the wealthier parts of the country. Other Latin American countries have specific characteristics that make the region heterogeneous, with different needs and difficulties.
What do you do that makes your center a successful recruiting center?
Working conditions vary in different parts of the world. Thus, one size does not fit all and we may not provide a formula useful for everybody. But our position in the dashboard of recruiting centers comes from a combination of factors that could be replicated elsewhere. It is related to the ability of a team to motivate others, showing that our motivation as investigators aligns with the role of everyone in the hospital in delivering high-standard healthcare.
We involved in the study all people in charge of the care of patients with cirrhosis, including medical and non-medical personnel. Our team is small but gained much experience with the previous ACLARA study. A dedicated nurse is responsible for the active search of patients, recruitment, and data upload. The surgical team in the operating room helps collect samples, but we trained people to correctly process and store samples.
Hospital das Clínicas da Universidade de São Paulo had a very active role in the ACLARA study. What was your experience with this project?
Instead of calling it ACLARA study, the most appropriate expression would be ACLARA experience. Personally, it was rewarding to take the responsibility to be the Latin American manager of one of the biggest studies sponsored by EF CLIF outside Europe. The same team that runs CHANCE at Hospital das Clinicas has participated in the activities of the regional office for the 44 centers in 7 countries integrating the ACLARA consortium. In a process of performance review, we reflected on our past accomplishments and the experience that we earned. We listed the qualities that would help us to be competitive, crafting a strategy to work better in future studies.
The CHANCE study is promoted by EF CLIF.
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
ClinicalTrials.gov Identifier: NCT04613921