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Completed

NCT Number: NCT02593799

Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study

Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Fibrosis Gastrointestinal Diseases Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

ANSTEEL Group Hospital, Anshan, Liaoning, China

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About this study

Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding. The investigators' recent systematic review evaluated the diagnostic accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex scores in predicting the presence of esophageal varices in liver cirrhosis. However, their diagnostic accuracy was low to moderate. Further study is warranted to establish a reliable score to predict the presence of high-risk esophageal varice in liver cirrhosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of liver cirrhosis.
  • Age and sex are not limited.
  • Etiology of liver cirrhosis is not limited.
  • Routine laboratory data.
  • Upper gastrointestinal endoscopy.

Exclusion criteria

  • Non-cirrhotic portal hypertension.
  • Malignancy.
  • Absent laboratory data.
  • A previous diagnosis of esophageal varices.
  • A previous history of variceal bleeding.

Treatment and study plan

endoscopy

Procedure

Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.

Primary outcomes

  1. Correlation of biochemical data with esophageal varices in liver cirrhosis

    Time frame: 18 months

    The investigators firstly calculated the significant factors associated with the presence of esophageal varices, and then developed a score to predict the presence of esophageal varices in liver cirrhosis.

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2015
Registry last updated
Feb 4, 2019

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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