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Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis

Completed
Conditions
Esophageal and Gastric Varices
Registration Number
NCT04210297
Lead Sponsor
Qilu Hospital of Shandong University
Brief Summary

The aim of the study is to develop and validate a new noninvasive method based on routine examination during clinical practice for predicting high risk esophageal varices in cirrhosis.

Detailed Description

Portal hypertension is the main consequence of cirrhosis. Variceal bleeding is the principal and life-threatening complication of portal hypertension. Endoscopic screening is the golden standard to detect esophageal varices. However, endoscopy is limited by its invasiveness, cost and the discomfort it imposes on patients. With the goal of circumventing these disadvantages, we intend to develop an noninvasive method for predicting high risk esophageal varices.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
245
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
specificitythrough study completion, up to 2 years

the specificity of predicting high risk esophageal varices of the noninvasive model.

Accuracythrough study completion, up to 2 years

The golden standard is endoscopic examination.Compare the accuracy of the noninvasive model with the endoscopic examination.

sensitivitythrough study completion, up to 2 years

the sensitivity of predicting high risk esophageal varices of the noninvasive model.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

🇨🇳

Jinan, Shandong, China

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