Image

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

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

Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

Inclusion Criteria:

  • 1. 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;

Exclusion Criteria:

  • 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 details
    Gastroesophageal Varices; Decompensation Event

NCT04890730

Nanfang Hospital, Southern Medical University

25 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.