About this trial
Background \& Rationale Severe alcohol-related hepatitis (SAH) is a serious condition with a 3-month mortality rate of \~30%. Diagnosis and prognosis are complex due to non-specific and insensitive clinical, biological, and histological indicators. Corticosteroids-the only validated treatment-are only effective in 50% of cases and can worsen outcomes in non-responders by promoting infections. Liver transplantation remains a limited option due to organ scarcity and patient eligibility.
TREM-1, a pro-inflammatory receptor, has shown promise in inflammatory liver diseases. Its expression in hepatocytes may serve as a biomarker to better classify patients, guide treatment, and improve outcomes.
Objectives
Primary Objective:
Compare TREM-1 expression (via immunohistochemistry) between SAH patients and controls with other liver diseases (e.g., HCC, metastatic colon cancer, cholangiocarcinoma).
Secondary Objectives:
Determine optimal antibody dilution for TREM-1 staining.
Assess diagnostic performance (sensitivity, specificity, PPV, NPV).
Identify homogeneous SAH subgroups using clinical, histological, and biological data.
Evaluate prognostic value of TREM-1 expression for:
2-month mortality
Corticosteroid response (bilirubin regression at Day 7)
Lille score \<0.45 at Day 7
Compare TREM-1's predictive power to standard scores (MELD, Maddrey, Lille, etc.).
Methodology
Population:
Cases: Adults treated at CHRU de Nancy (2013-2023) for SAH, with archived liver biopsies.
Controls: Adults with liver malignancies and archived biopsies.
Sample Size:
Phase I: 12 cases, 6 controls
Phase II: 150 cases, 150 controls
Data Sources: Medical records, archived pathology slides
Statistical Tools: Logistic regression, survival analysis, ROC curves, clustering, SAS/R software
Expected Outcomes \& Impact Improved prognostic stratification and therapeutic guidance for SAH patients
Better targeting of corticosteroid therapy to reduce unnecessary risk
Early referral for liver transplantation when appropriate
Validation of TREM-1 as a diagnostic/prognostic biomarker
Foundation for future TREM-1-targeted clinical trials
Potential paradigm shift linking liver histology with real-time clinical decision-making
Enhanced resource allocation and patient management
Eligibility criteria
Qualifiers
Individuals who received full information about the study and did not object to the use of their data within this research.
Patients managed in one of the intensive care or hepatogastroenterology departments at CHRU de Nancy for severe alcohol-related hepatitis between January 1, 2013, and December 31, 2023.
Archived liver biopsy slides available at CHRU de Nancy.
Adult patients at the time of diagnosis.
Disqualifiers
None
Trial design
Treatments tested in this trial
- TREM-1 expression (via immunohistochemistry) between SAH patients and controls