The Liver Cirrhosis Network Cohort Study: Cirrhosis Definition, Study Population, and Endpoints
Year: 2024
Type: article
Study design: Study Protocol
Abstract: INTRODUCTION: One of the primary goals of the Liver Cirrhosis Network (LCN) is to develop a cohort study to better understand and predict the risk of hepatic decompensation and other clinical and patient-reported outcomes among patients with Child A cirrhosis. METHODS: The LCN consists of a Scientific Data Coordinating Center and 10 clinical centers whose investigators populate multiple committees. The LCN Definitions and Measurements Committee developed preliminary definitions of cirrhosis and its complications by literature review, expert opinion, and reviewing definition documents developed by other organizations. The Cohort Committee developed the study protocol with the input of the steering committee. RESULTS: The LCN developed a prospective cohort study to describe and predict the rates of incident clinical events pertaining to first decompensation and patient-reported outcomes. The LCN developed a pragmatic definition of compensated cirrhosis incorporating clinical, laboratory, imaging, and histological criteria. Definitions of incident and recompensated ascites, overt hepatic encephalopathy, variceal hemorrhage, bleeding because of portal gastropathy, and hepatocellular carcinoma were also codified. DISCUSSION: The LCN Cohort Study design will inform the natural history of cirrhosis in contemporary patients with compensated cirrhosis. The LCN Definitions and Measures Committee developed criteria for the definition of cirrhosis to standardize entry into this multicenter cohort study and standardized criteria for liver-related outcome measures. This effort has produced definitions intended to be both sensitive and specific as well as easily operationalized by study staff such that outcomes critical to the LCN cohort are identified and reported in an accurate and generalizable fashion. REGISTRATION: NCT05740358.
Authors: Elliot B. Tapper, David Goldberg, Neehar D. Parikh, Norah A. Terrault, Nicole Welch, Suzanne Sharpton, Bilal Hameed, Mandana Khalili, Andrew Stolz, Elizabeth C. Verna, Robert S. Brown, Arun J. Sanyal, Lisa VanWagner, Daniela P. Ladner, Cynthia A. Moylan, Anna Mae Diehl, Patricia D. Jones, Rohit Loomba, Srinivasan Dasarathy, Douglas A. Simonetto, Vijay H. Shah, Jasmohan S. Bajaj, for the LCN Study Group
Institutions: University of Michigan, Michigan Medicine, University of Miami, University of Southern California, Keck Hospital of USC, Cleveland Clinic, University of California San Diego, University of California, San Francisco, Columbia University, Weill Cornell Medicine, Virginia Commonwealth University, Hunter Holmes McGuire VA Medical Center, Virginia Commonwealth University Medical Center, The University of Texas Southwestern Medical Center, Northwestern University, Duke University, Duke Medical Center, Mayo Clinic
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G2128731429, G3331858215, G4668430120, G4944655903, G5111001695, G589558175, G6538143809, G6615941051, USC Cirrhosis Clinical Center, Alcohol and tissue injury, from mechanisms to treatments, Strategies and Therapies for Outcomes Prevention in Cirrhosis: The STOP-C Liver Cirrhosis Network, Liver Cirrhosis Network: Clinical Research Center - Mayo Clinic, Liver Cirrhosis Network: Longitudinal and Clinical Trial Studies, San Diego Cirrhosis Clinical Research Network
OpenAlex ID: W4400729419