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OpenTrials
Completed

NCT Number: NCT04850534

Systemic Inflammation in Liver Cirrhosis

Investigate systemic inflammation in liver cirrhosis patients

Completed

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510630, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Upper Gastrointestinal Bleeding

    Time frame: 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

  2. Death

    Time frame: One Year

    Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc

Secondary outcomes

  1. New or worsening acute decompensation event other than upper GI bleeding

    Time frame: 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

  2. Liver transplantation/ Transfer to other non-endoscopic therapies

    Time frame: One Year

    Undergo liver transplantation, or transferred to surgical, radio-interventional, or other non-endoscopic therapies; Measured by number/proportion of patients

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients

Acronym: SILC

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 20, 2021
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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