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

Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants at Pitié Salpêtrière University Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis
• Intervention / Treatment: Other: Data collection; biological samples

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Dominique THABUT, MD, PhD; Phone Number: +33 1 42 17 57 55; Email: dominique.thabut@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Pitie Salpetriere University Hospital
    • Contact: Dominique THABUT, MD, PhD; Phone Number: 01 42 17 57 55; Email: dominique.thabut@aphp.fr
  • Paris, France, 75013
    • Recruiting
    • Digestive Surgery Department, Pitié-Salpêtrière Hospital
    • Contact: Olivier Scatton, MD, PhD; Phone Number: +33 1-42-16-05-92; Email: olivier.scatton@aphp.fr
  • Paris, France, 75013
    • Recruiting
    • Intensive Care Unit, Pitié Salpêtrière Hospital
    • Contact: Antoine MONSEL, MD, PhD; Phone Number: +33 1-84-82-73-99; Email: antoine.monsel@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Data collection; biological samples; 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. Moreover, residual liver tissues from medical procedures (biopsies or surgical specimens) will be collected and analyzed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of survival in cirrhosis and liver transplant patients.	Overall survival will be determined by the time between diagnosis and death of patients with cirrhosis or liver transplants.	During patient follow-up, for maximum 9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the occurrence of complications (digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer) in patients with cirrhosis or liver transplants.	Patients will be followed longitudinally, and the occurrence and timing of complications (digestive bleeding, ascites, hepatic encephalopathy, infections and primary liver cancer) will be recorded for each patient.	During patient follow-up, for maximum 9 years
Identification of clinico-biological predictors of cirrhosis-related or post-TH complications.	Clinico-biological and imaging data collected from patients' diagnosis will be correlated with overall survival and the occurrence of complications (digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer).	At inclusion
Evaluation of the number of liver transplant patients with cirrhosis-related complications	The number of cirrhotic patients with complications (digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer) will then be followed longitudinally, and the number of patients requiring TH for these complications will be collected.	During patient follow-up, for maximum 9 years
Determination of exosome profile in patients with tumor complication of cirrhosis or post-TH	Cirrhotic and TH patients will be followed longitudinally with regular sampling to monitor exosome profiles, sex steroid hormones and immune profiles (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptomic profiles, etc.) during cirrhotic disease and TH (objectives 4, 5 and 6).	During patient follow-up, for maximum 9 years
Determination of sex steroid hormone profile during cirrhotic disease or post-TH.	Cirrhotic and TH patients will be followed longitudinally with regular sampling to monitor exosome profiles, sex steroid hormones and immune profiles (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptomic profiles, etc.) during cirrhotic disease and TH (objectives 4, 5 and 6).	During patient follow-up, for maximum 9 years
Immune status in cirrhotic or post-TH patients (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptome profiles ...)	Cirrhotic and TH patients will be followed longitudinally with regular sampling to monitor exosome profiles, sex steroid hormones and immune profiles (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptomic profiles, etc.) during cirrhotic disease and TH (objectives 4, 5 and 6).	During patient follow-up, for maximum 9 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): March 19, 2040
• Study Completion (Estimated): March 19, 2040

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: liver transplantation; alcohol; metabolic syndrome; hepatitis B and C
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Metabolic Diseases; Infections; Virus Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Insulin Resistance; Hyperinsulinism; Hepadnaviridae Infections; Hepatitis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Metabolic Syndrome; Fibrosis; Hepatitis B; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: APHP231630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No