Systemic Inflammation in Liver Cirrhosis

Liver Cirrhosis Clinical Trial

— SILC  

Official title:

Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850534
• Other study ID #: SILC
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigate systemic inflammation in liver cirrhosis patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 30, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Inflammation
• Liver Cirrhosis

Locations

Country	Name	City	State
China	Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Death	Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc	One Year
Secondary	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
Secondary	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