Systemic Inflammation in Liver Cirrhosis (SILC)

Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients

Investigate systemic inflammation in liver cirrhosis patients

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients of liver cirrhosis with high-risk bleeding esophaogastric varices

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
EGD+NSBB; Patients receiving both endoscopic therapy and non-selective beta-blockers for treating high-risk esophagogastric varices
EGD; Patients receiving mono endoscopic therapy for treating high-risk esophagogastric varices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Gastrointestinal Bleeding	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	One Year
Death	Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New or worsening acute decompensation event other than upper GI bleeding	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	One Year
Liver transplantation/ Transfer to other non-endoscopic therapies	Undergo liver transplantation, or transferred to surgical, radio-interventional, or other non-endoscopic therapies; Measured by number/proportion of patients	One Year

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Bin Wu, Ph.D, Department of Gastroenterology, Third Affiliated Hospital of Sun Yar-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Liver cirrhosis; Systemic inflammation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Inflammation; Liver Cirrhosis
• Other Study ID Numbers: SILC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No