Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis
- Conditions
- Decompensated CirrhosisHepatitis B
- Interventions
- Other: no intervention
- Registration Number
- NCT05086536
- Lead Sponsor
- Beijing Friendship Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
-
Ascites and/or variceal hemorrhage (VH) as the first decompensated events;
-
Initiating antiviral therapy within 3 months of the first decompensated events;
-
Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,
-
Clinical outcomes were classified:
- Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available.
- With ≥ 2 episodes of decompensation: medical records for decompensation were available.
- Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
- Liver transplantation /death within 6 months of first decompensated events;
- complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
- Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
- Pregnant women.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description early stage decompensation cohort no intervention Patients occurred first decompensated events and initiating nucleoside analogs (NUCs) based treatment within 3 months were retrospectively included.
- Primary Outcome Measures
Name Time Method Cumulative incidence of re-compensation Year 5 Patients who did not occur further decompensation
- Secondary Outcome Measures
Name Time Method Cumulative incidence of re-compensation Year 1, 2, 3, and 4 Patients who did not occur further decompensation
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
Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group Year 1, 2, 3, 4, and 5 Child-Pugh
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
Cumulative incidence of HCC Year 1, 2, 3, 4, and 5 Patients who occurred HCC
Dynamic changes of MELD score in re-compensated and not re-compensated group Year 1, 2, 3, 4, and 5 MELD
Trial Locations
- Locations (7)
The Second Affiliated Hospital of Baotou Medical Coll
🇨🇳Baotou, Inner Mongolia, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
XiangYa Hospital Central South University
🇨🇳Changsha, Hunan, China
Beijing YouAn Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China