Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants

NCT ID: NCT06544863

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2040-03-19

Brief Summary

Cirrhosis is a major challenge in France, with a growing prevalence of 1,500 to 2,500 cases per million inhabitants, and the discovery of 150 to 200 new cases per million inhabitants each year. The main causes are alcohol, hepatitis B and C, and metabolic syndrome. Severe complications of cirrhosis, such as digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer, require frequent hospitalization and are more common in advanced stages of the disease. Around 15,000 deaths occur each year, affecting relatively young patients with an average age of 55. At the moment, the only treatment for these patients is liver transplantation (LT), although this is not feasible for all patients, and many complications may arise post LT.

Biological collections play an essential role in research, enabling the collection and storage of biological samples and clinical data to understand disease mechanisms and develop new therapeutic approaches or post-transplant follow-up. Longitudinal studies following the course of the disease offer a better understanding of risk factors and prognostic determinants. In this way, cirrhosis care support is constantly evolving, thanks to the evaluation of practices and the continuous improvement of patient care. For patients in whom TH is feasible, biological collections are also important for research and evaluation, and help improve post-TH care.

Detailed Description

Cirrhosis is a major challenge for healthcare professionals in France, with a growing prevalence in the country of over 1,500 to 2,500 diagnosed cases per million inhabitants, and the annual discovery of around 150 to 200 new cases per million inhabitants. The main causes of cirrhosis in France are excessive alcohol consumption, chronic viral hepatitis B and C, and metabolic syndrome. In the course of cirrhosis, severe complications can arise, such as digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer, requiring frequent hospitalization. These complications are more frequent in advanced cirrhosis, and may require liver transplantation. Around 15,000 deaths occur each year in France due to cirrhosis, affecting relatively young patients with an average age of 55. Currently, the only treatment for these patients is liver transplantation (LT), although this is not feasible for all patients, and many complications may arise post-LT. In order to improve the prognosis of patients with cirrhosis, several questions remain unanswered, such as the early diagnosis of cirrhosis in at-risk subjects, the identification of cirrhotic patients at high risk of complications, and the search for factors predictive of response to treatment of the various complications. The establishment of biological collections plays an essential role in research into cirrhosis and its complications, as well as the progression to TH and these complications. These biological collections enable the systematic collection and storage of biological samples and clinical data from cirrhosis and/or transplant patients. These resources are crucial for understanding the underlying mechanisms of the disease, identifying new diagnostic and prognostic biomarkers, and developing new therapeutic approaches.The development of a biological collection also offers the possibility of conducting longitudinal studies, tracking the progression of the disease in cirrhosis patients and/or post-TH. This enables a better understanding of risk factors, prognostic determinants and individual variations in disease progression. Thus, cirrhosis care support is constantly evolving, and the follow-up of a prospective cohort makes it possible to evaluate practices, determine prognostic factors and continually improve the management of patients, whether or not they are transplanted.

Conditions

Cirrhosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cirrhosis or suspected cirrhosis and/or TH patient

Patients with a diagnosis or suspected diagnosis of cirrhosis and/or TH managed at Pitié Salpêtrière University Hospital

Data collection and blood sample

Intervention Type: OTHER

In addition to collecting medical data, additional blood samples will be collected in order to create a biological collection and identify biomarkers associated with the occurrence of cirrhosis-related complications, progression to TH and follow-up.

Interventions

Data collection and blood sample

In addition to collecting medical data, additional blood samples will be collected in order to create a biological collection and identify biomarkers associated with the occurrence of cirrhosis-related complications, progression to TH and follow-up.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Patients managed for cirrhosis or suspected cirrhosis and/or TH at Pitié Salpêtrière University Hospital
• Patients having been informed and having signed the consent to participate in the study.

Exclusion Criteria

• Patient under legal protection (guardianship, curatorship)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Digestive Surgery Department, Pitié-Salpêtrière Hospital

Paris, , France

Site Status: RECRUITING

Intensive Care Unit, Pitié Salpêtrière Hospital

Paris, , France

Site Status: RECRUITING

Pitié Salpêtrière University Hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Dominique THABUT, MD, PhD

Role: CONTACT

dominique.thabut@aphp.fr

+33 1 42 17 57 55

Facility Contacts

Olivier Scatton, MD, PhD

Role: primary

olivier.scatton@aphp.fr

1-42-16-05-92 ext. +33

Antoine MONSEL, MD, PhD

Role: primary

antoine.monsel@aphp.fr

1-84-82-73-99 ext. +33

Dominique THABUT, MD, PhD

Role: primary

dominique.thabut@aphp.fr

01 42 17 57 55

Other Identifiers

APHP231630

Identifier Type: -

Identifier Source: org_study_id