Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients

Third Affiliated Hospital, Sun Yat-Sen University1 site in 1 country400 target enrollmentApril 1, 2019

ConditionsLiver Cirrhosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Liver Cirrhosis
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Enrollment: 400
Locations: 1
Primary Endpoint: Upper Gastrointestinal Bleeding
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Investigate systemic inflammation in liver cirrhosis patients

Registry

clinicaltrials.gov

Start Date

April 1, 2019

End Date

October 30, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Responsible Party

Principal Investigator

Jinlai Liu

Clinical Professor

Third Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

•Decompensated liver cirrhosis, with endoscopy-verified high-risk esophagogastric varices;
•Adult patients aged 18-75 years;
•Willing to anticipate and informed consent form obtained

Exclusion Criteria

•History of prior radio-interventional therapy (TIPS or BRTO), liver transplantation, splenectomy, or hepatectomy;
•Non-sinusoidal cirrhosis (e.g. vascular cirrhosis);
•Coexistence with advanced hepatocellular carcinoma or other malignancies;
•Coexistence with severe systemic diseases and less than 3 months of expected survival time;
•Acute infection within 4 weeks before recruitment;
•Antibiotic use within 4 weeks before recruitment;
•Initial antiviral therapy for HBV or HCV within 4 weeks before recruitment;
•Pregnant or lactating women;
•Patients resistant to long-term follow-up

Outcomes

Primary Outcomes

Upper Gastrointestinal Bleeding

Time Frame: One Year

Overt upper GI bleeding due to esophagogastric varices, ulcers and other causes; Identified by clinical manifestations, lab tests and endoscopy and measured by number/proportion of patients

Death

Time Frame: One Year

Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc

Secondary Outcomes

New or worsening acute decompensation event other than upper GI bleeding(One Year)
Liver transplantation/ Transfer to other non-endoscopic therapies(One Year)