Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis

• Conditions: Portal Hypertension; Gastroesophageal Varices

• Registration Number: NCT04123509
• 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, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis of cirrhosis.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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-09
• Status Verified: 2019-08
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-11
• Last Update Posted: 2019-10-11
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 616

Inclusion Criteria

1. The age ranged from 18 to 75 years.
2. Clinical or pathological diagnosis of cirrhosis;
3. Electronic gastroscopy is planned;
4. To agree and sign the informed consent;

Exclusion Criteria

1. Hepatocellular carcinoma or other malignant tumors have been or are currently diagnosed;
2. Orthotopic liver transplantation patients;
3. Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt;
4. Pregnant women;
5. Neurological or psychiatric disorders;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
high-risk esophageal varices	2 years	Incidence of high-risk esophageal varices

Secondary Outcome Measures

Name	Time	Method
bleeding event happen	2 years	Incidence of hemorrhagic events

Trial Locations

Locations (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China