Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation

Overview

The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 31, 2025

Detailed Description

The research study is designed to improve the investigators' understanding of early liver transplantation for patients with severe alcoholic hepatitis. The goal of this research is twofold: 1. Establish a knowledge base necessary for appropriate liver transplant candidate selection by quantifying post-ELT mortality for SAH and compare to outcomes to liver transplantation for other indications 2. Develop an ethical framework for implementation of these transplants for SAH based on the opinions of healthcare providers and the general public.

Interventions

  • Procedure: liver transplant
    • solid organ transplant

Arms, Groups and Cohorts

  • Retrospective Cohort
    • Early Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH)
  • Prospective Cohort 1
    • Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH)
  • Prospective Cohort 2
    • Orthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD)

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants who survived within 1 year post-transplant
    • Time Frame: 1 years
    • Post-transplant survival within one year of the surgical procedure.

Secondary Measures

  • Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant
    • Time Frame: 1 years
    • Self-reported or biochemically measured alcohol recidivism or relapse.

Participating in This Clinical Trial

Inclusion Criteria for Severe Alcoholic Hepatitis patients:

  • Patients with Severe Alcoholic Hepatitis (SAH) listed for liver transplantation at Johns Hopkins Hospital (JHH), have not been sober for at least 6 months at time of waitlisting, and are at least 18 years old. Exclusion Criteria for Severe Alcoholic Hepatitis patients: – Non-SAH patients listed for liver transplantation at JHH and patients who have been sober for at least 6 months at the time of waitlisting. Inclusion Criteria for non-SAH comparison group: – Patients 18 years or older undergoing liver transplantation at JHH for alcoholic liver disease and were sober for at least 6 months prior to transplantation. Exclusion Criteria for non-SAH comparison group: – Patients who do not meet inclusion criteria.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrew M Cameron, MD, PhD, Principal Investigator, Johns Hopkins University

References

Lee BP, Chen PH, Haugen C, Hernaez R, Gurakar A, Philosophe B, Dagher N, Moore SA, Li Z, Cameron AM. Three-year Results of a Pilot Program in Early Liver Transplantation for Severe Alcoholic Hepatitis. Ann Surg. 2017 Jan;265(1):20-29. doi: 10.1097/SLA.0000000000001831.

Weeks SR, Sun Z, McCaul ME, Zhu H, Anders RA, Philosophe B, Ottmann SE, Garonzik Wang JM, Gurakar AO, Cameron AM. Liver Transplantation for Severe Alcoholic Hepatitis, Updated Lessons from the World's Largest Series. J Am Coll Surg. 2018 Apr;226(4):549-557. doi: 10.1016/j.jamcollsurg.2017.12.044. Epub 2018 Feb 2.

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