Systemic Inflammation in Liver Cirrhosis

NCT04850534 | Completed

• 1 other identifier: SILC
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Investigate systemic inflammation in liver cirrhosis patients

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosis; Systemic inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• New or worsening acute decompensation event other than upper GI bleeding

  One Year

• Liver transplantation/ Transfer to other non-endoscopic therapies

  One Year

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of liver cirrhosis with high-risk bleeding esophaogastric varices

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bin Wu, Ph.D

  Department of Gastroenterology, Third Affiliated Hospital of Sun Yar-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 20, 2021
• Study Start: April 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: October 30, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

CN (1)