An observational study in Gastroesophageal Varices; Decompensation Event, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
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.
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.
169 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.
This study's planned enrollment of 992 is above the median of 130 across 51 observational studies indexed under Esophageal and Gastric Varices.
Browse Esophageal and Gastric Varices studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
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Patients who come to the center to see a doctor who meet the enrollment criteria and agree to participate in the study
Exclusion Criteria:
Southern Medical University of Nanfang Hospital
Other: Esophagogastroduodenoscopies
Tongji Hospital Affiliated to Tongji University
Other: Esophagogastroduodenoscopies
The Second Affiliated Hospital Of Nanchang University
Other: Esophagogastroduodenoscopies
Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography
Incidence of high-risk esophageal varices
Incidence of high-risk esophageal varices
Time frame: 4 years
Incidence of hemorrhagic events
Incidence of hemorrhagic events
Time frame: 4 years
Incidence of Clinical decompensation events and deaths
Incidence of Clinical decompensation events and deaths
Time frame: 4 years
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Esophageal and Gastric Varices→
Nanfang Hospital, Southern Medical University