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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal and Gastric Varices

Participation Criteria
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Eligibility Criteria
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The inclusion criteria: patients who were diagnosed with liver cirrhosis. patients who underwent the abdominal contrast-enhanced CT examination. patients who received endoscopic screening. patients with written informed consent. The exclusion criteria: patients who previously underwent endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, partial splenic embolization (PSE), hepatectomy, balloon-occluded retrograde transvenous obliteration, or liver transplantation. patients with liver cancer. patients with severe ascites or hepatic encephalopathy. lacks abdominal contrast-enhanced CT within 1 month of endoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training cohort<br>Training cohort consists of the cirrhotic patients who collected from January 2018 to December 2019 of Qilu Hospital retrospectively. | |
| Internal validation cohort<br>Internal validation cohort consists of the cirrhotic patients who enrolled from January 2020 of Qilu Hospital prospectively. | |
| External validation cohort<br>External validation cohort consists of the cirrhotic patients who enrolled from January 2020 in Jinan Central Hospital prospectively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | The golden standard is endoscopic examination.Compare the accuracy of the noninvasive model with the endoscopic examination. | through study completion, up to 2 years | 
| sensitivity | the sensitivity of predicting high risk esophageal varices of the noninvasive model. | through study completion, up to 2 years | 
| specificity | the specificity of predicting high risk esophageal varices of the noninvasive model. | through study completion, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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noninvasive, portal hypertension, radiomics