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

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

Sponsors

Lead sponsor: Nanfang Hospital of Southern Medical University

Source Nanfang Hospital of 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.

Overall Status Recruiting
Start Date April 9, 2019
Completion Date January 31, 2021
Primary Completion Date December 31, 2020
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
high-risk esophageal varices 2 years
Secondary Outcome
Measure Time Frame
bleeding event happen 1 year
bleeding event happen 2 years
Enrollment 616
Condition
Eligibility

Sampling method: Probability Sample

Criteria:

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;

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Contact

Last name: Jinjun Chen, PHD

Phone: 8618588531001

Email: [email protected]

Location
facility status contact Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University Jinjun Chen, PHD 86-18588531001 [email protected]
Location Countries

China

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Observational model: Cohort

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov