Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis-a Prospective, Multicenter Trial

Study Overview
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Brief Summary
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Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is an unsatisfactory screening test.In this prospective clinical study,we will enroll patients with cirrhosis of various causes, all of whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including liver elastography (LSM) and spleen elastography (SSM). Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM and PLT. LSM, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis with varices. At the same time, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found. And each patient will be followed up every 6 months to 1 year, and the outcome event will be recorded.

Detailed Description
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Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is invasive method as an unsatisfactory screening test.In this prospective clinical study, we will enroll patients with cirrhosis of various causes, all of patients whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including LSM and SSM. Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM and PLT. LSM,SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis with varices. At the same time, based on SSM and serum differential protein, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found. And each patient will be followed up every 6 months to 1 year, and the outcome event will be recorded.

Official Title
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Southern Medical University of Nanfang Hospital

Conditions
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Gastroesophageal Varices; Decompensation Event

Intervention / Treatment
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* Other: Esophagogastroduodenoscopies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. The age ranged from 18 to 80 years. 2. Clinical or pathological diagnosis of cirrhosis; 3. Electronic gastroscopy is planned; 4. To agree and sign the informed consent; Exclusion Criteria: 1.Orthotopic liver transplantation patients; 2. Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt; 3. Pregnant women; 4. Neurological or psychiatric disorders;

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

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Southern Medical University of Nanfang Hospital<br>Southern Medical University of Nanfang Hospital | Other: Esophagogastroduodenoscopies<br>* Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography<br>|
| Tongji Hospital Affiliated to Tongji University<br>Tongji Hospital Affiliated to Tongji University | Other: Esophagogastroduodenoscopies<br>* Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography<br>|
| The Second Affiliated Hospital Of Nanchang University<br>The Second Affiliated Hospital Of Nanchang University | Other: Esophagogastroduodenoscopies<br>* Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of high-risk esophageal varices | Incidence of high-risk esophageal varices | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hemorrhagic events | Incidence of hemorrhagic events | 4 years | 
| Incidence of Clinical decompensation events and deaths | Incidence of Clinical decompensation events and deaths | 4 years |