Systemic Inflammation in Liver Cirrhosis

Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04850534

Acronym

SILC

Enrollment

400

Registered

2021-04-20

Start date

2019-04-01

Completion date

2023-10-30

Last updated

2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosis; Systemic inflammation

Brief summary

Investigate systemic inflammation in liver cirrhosis patients

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results