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

Completed
Conditions
Liver Cirrhosis
Esophageal and Gastric Varices
Interventions
Procedure: Endoscopy
Registration Number
NCT02593799
Lead Sponsor
General Hospital of Shenyang Military Region
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
363
Inclusion Criteria
  1. A diagnosis of liver cirrhosis.
  2. Age and sex are not limited.
  3. Etiology of liver cirrhosis is not limited.
  4. Routine laboratory data.
  5. Upper gastrointestinal endoscopy.
Exclusion Criteria
  1. Non-cirrhotic portal hypertension.
  2. Malignancy.
  3. Absent laboratory data.
  4. A previous diagnosis of esophageal varices.
  5. A previous history of variceal bleeding.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients with esophageal varicesEndoscopyEsophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices.
Patients without esophageal varicesEndoscopyPatients without esophageal varices were divided into patients without "any grade" or "high-risk" varices.
Primary Outcome Measures
NameTimeMethod
Correlation of biochemical data with esophageal varices in liver cirrhosis18 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (17)

ANSTEEL Group Hospital

🇨🇳

Anshan, Liaoning, China

First Affiliated Hospital of Dalian Medical University

🇨🇳

Dalian, Liaoning, China

Friendship Hospital of Dalian City

🇨🇳

Dalian, Liaoning, China

Central Hospital of Dandong City

🇨🇳

Dandong, Liaoning, China

Central Hospital of Fushun City

🇨🇳

Fushun, Liaoning, China

General Hospital of Mining Industry Group Fuxin

🇨🇳

Fuxin, Liaoning, China

First Affiliated Hospital of Liaoning Medical University

🇨🇳

Jinzhou, Liaoning, China

General Hospital of Liaoyang City

🇨🇳

Liaoyang, Liaoning, China

Central Hospital of Panjin City

🇨🇳

Panjing, Liaoning, China

General Hospital of Liaohe Oil Field

🇨🇳

Panjing, Liaoning, China

Central Hospital Affiliated to Shenyang Medical College

🇨🇳

Shenyang, Liaoning, China

Department of Gastroenterology, General Hospital of Shenyang Military Area

🇨🇳

Shenyang, Liaoning, China

No. 1 of Department of Gastroenterology, Liaoning Provincial People's Hospital

🇨🇳

Shenyang, Liaoning, China

No. 2 of Department of Gastroenterology, Liaoning Provincial People's Hospital

🇨🇳

Shenyang, Liaoning, China

Shengjing Hospital of Chinese Medical University

🇨🇳

Shenyang, Liaoning, China

Shuangshan Hospital of Anshan City

🇨🇳

Anshan, Liaoning, China

First Affiliated Hospital of Chinese Medical University

🇨🇳

Shenyang, Liaoning, China

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