Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis-a Prospective, Multicenter Trial
- Conditions
- Gastroesophageal Varices; Decompensation Event
- Interventions
- Other: Esophagogastroduodenoscopies
- Registration Number
- NCT04890730
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 992
-
- 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;
- 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;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tongji Hospital Affiliated to Tongji University Esophagogastroduodenoscopies Tongji Hospital Affiliated to Tongji University Southern Medical University of Nanfang Hospital Esophagogastroduodenoscopies Southern Medical University of Nanfang Hospital The Second Affiliated Hospital Of Nanchang University Esophagogastroduodenoscopies The Second Affiliated Hospital Of Nanchang University
- Primary Outcome Measures
Name Time Method Incidence of high-risk esophageal varices 4 years Incidence of high-risk esophageal varices
- Secondary Outcome Measures
Name Time Method Incidence of hemorrhagic events 4 years Incidence of hemorrhagic events
Incidence of Clinical decompensation events and deaths 4 years Incidence of Clinical decompensation events and deaths
Trial Locations
- Locations (1)
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, China