Systemic Inflammation in Liver Cirrhosis

Completed

• Conditions: Liver Cirrhosis

• Registration Number: NCT04850534
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Investigate systemic inflammation in liver cirrhosis patients

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-20
• Primary Completion: 2022-12-31
• Study Completion: 2023-10-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Upper Gastrointestinal Bleeding	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	One Year	Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc

Secondary Outcome Measures

Name	Time	Method
New or worsening acute decompensation event other than upper GI bleeding	One Year	Ascites, Hepatic encephalopathy, systemic infection, spontaneous bacterial peritonitis, hepatorenal syndrome, etc Identified by clinical manifestations, lab tests and images according to renown practice guidelines and measured by number/proportion of patients
Liver transplantation/ Transfer to other non-endoscopic therapies	One Year	Undergo liver transplantation, or transferred to surgical, radio-interventional, or other non-endoscopic therapies; Measured by number/proportion of patients

Trial Locations

Locations (1)

Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China