Decompensated Cirrhosis, Hepatitis B
Conditions
Keywords
re-compensation, treatment-naive, HBV, decompensation
Brief summary
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.
Detailed description
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. WBC, RBC, HGB, PLT, CRP, PT, PTA, INR, ALT, AST, TB, DB, ALB, GLO, ALP, GGT, CHE, BUN, Cr, Na, GLU, CHOL, TG, HDL-C, LDL-C, AFP, HBsAg, HBV-DNA, LSM, BUS, MRI/CT and gastroscope from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. This retrospective study aimed to explore the incidence of re-compensation and its clinical characteristics.
Interventions
OTHERno intervention
This is a retrospective and observational study.
Sponsors
Beijing YouAn Hospital
Shandong Provincial Hospital
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Shanxi Medical University
Xiangya Hospital of Central South University
The Second Affiliated Hospital of Baotou Medical College
Beijing Friendship Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Ascites and/or variceal hemorrhage (VH) as the first decompensated events; 2. Initiating antiviral therapy within 3 months of the first decompensated events; 3. Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS, 4. Clinical outcomes were classified: 1. Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available. 2. With ≥ 2 episodes of decompensation: medical records for decompensation were available.
Exclusion criteria
1. Hepatocellular carcinoma prior to /within 6 months of first decompensated events; 2. Liver transplantation /death within 6 months of first decompensated events; 3. complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD. 4. Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases; 5. Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of re-compensation | Year 5 | Patients who did not occur further decompensation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annual incidence of second decompensation | Year 1, 2, 3, 4, and 5 | Patients who occurred second decompensation |
| Cumulative incidence of liver-related death / liver transplantation | Year 1, 2, 3, 4, and 5 | Patients who died of decompensation |
| Cumulative incidence of HCC | Year 1, 2, 3, 4, and 5 | Patients who occurred HCC |
| Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group | Year 1, 2, 3, 4, and 5 | Child-Pugh |
| Cumulative incidence of re-compensation | Year 1, 2, 3, and 4 | Patients who did not occur further decompensation |
| Dynamic changes of APRI score in re-compensated and not re-compensated group | Year 1, 2, 3, 4, and 5 | APRI |
| Dynamic changes of FIB-4 score in re-compensated and not re-compensated group | Year 1, 2, 3, 4, and 5 | FIB-4 |
| Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group | Year 1, 2, 3, 4, and 5 | Liver stiffness |
| Dynamic changes of MELD score in re-compensated and not re-compensated group | Year 1, 2, 3, 4, and 5 | MELD |
Countries
China
Contacts
Primary ContactHong You, Doctor
Backup ContactJialing Zhou, Master
Outcome results
None listed