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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02593799
Enrollment
363
Registered
2015-11-02
Start date
2015-05-01
Completion date
2018-12-31
Last updated
2019-02-04

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

Conditions

Esophageal and Gastric Varices, Liver Cirrhosis

Keywords

Liver cirrhosis, Esophageal and Gastric Varices, Endoscopy

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.

Interventions

PROCEDUREEndoscopy

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

Sponsors

General Hospital of Shenyang Military Region
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation of biochemical data with esophageal varices in liver cirrhosis18 monthsThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026