Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

Beijing Friendship Hospital600 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Hepatitis B Decompensated Cirrhosis

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (7)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

XiangYa Hospital Central South University

Changsha, Hunan, China

The Second Affiliated Hospital of Baotou Medical Coll

Baotou, Inner Mongolia, China

Shandong Provincial Hospital

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Outcomes

Primary Outcomes

Cumulative incidence of re-compensation

Patients who did not occur further decompensation

Time frame: Year 5

Secondary Outcomes

Cumulative incidence of re-compensation

Patients who did not occur further decompensation

Time frame: Year 1, 2, 3, and 4

Annual incidence of second decompensation

Patients who occurred second decompensation