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

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04123509
• Other study ID #: 011
• Status: Recruiting
• Start date: April 9, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: August 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinjun Chen, PHD
• Phone: 8618588531001
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 616
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastroesophageal Varices
• Hypertension, Portal
• Portal Hypertension
• Varicose Veins

Locations

Country	Name	City	State
China	Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high-risk esophageal varices	Incidence of high-risk esophageal varices	2 years
Secondary	bleeding event happen	Incidence of hemorrhagic events	1 year
Secondary	bleeding event happen	Incidence of hemorrhagic events	2 years