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

Southern Medical University of Nanfang Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Varices; Decompensation Event
• Intervention / Treatment: Other: Esophagogastroduodenoscopies

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 992

Contacts and Locations

• Study Contact: Name: Jinjun Chen, PHd; Phone Number: 8618588531001; Email: chjj@smu.edu.cn
• Study Contact Backup: Name: Haiyu Wang; Phone Number: 15602203979; Email: 375612668@qq.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
    • Contact: Jinjun Chen, PHD; Phone Number: 86-18588531001; Email: chjj@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who come to the center to see a doctor who meet the enrollment criteria and agree to participate in the study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Southern Medical University of Nanfang Hospital	Other: Esophagogastroduodenoscopies; Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography
Tongji Hospital Affiliated to Tongji University	Other: Esophagogastroduodenoscopies; Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography
The Second Affiliated Hospital Of Nanchang University	Other: Esophagogastroduodenoscopies; Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of high-risk esophageal varices	Incidence of high-risk esophageal varices	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hemorrhagic events	Incidence of hemorrhagic events	4 years
Incidence of Clinical decompensation events and deaths	Incidence of Clinical decompensation events and deaths	4 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Publications and helpful links

General Publications

• Zhang X, Song J, Zhang Y, Wen B, Dai L, Xi R, Wu Q, Li Y, Luo X, Lan X, He Q, Luo W, Lai Q, Ji Y, Zhou L, Qi T, Liu M, Zhou F, Wen W, Li H, Liu Z, Chen Y, Zhu Y, Li J, Huang J, Cheng X, Tu M, Hou J, Wang H, Chen J. Baveno VII algorithm outperformed other models in ruling out high-risk varices in individuals with HBV-related cirrhosis. J Hepatol. 2023 Mar;78(3):574-583. doi: 10.1016/j.jhep.2022.10.030. Epub 2022 Nov 7.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 16, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices
• Other Study ID Numbers: NFEC-2020-222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No