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

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

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.

Study Overview

• Status: Unknown
• Conditions: Portal Hypertension; Gastroesophageal Varices

• Study Type: Observational
• Enrollment (Anticipated): 616

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • 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 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cirrhosis of various etiologies

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high-risk esophageal varices	Incidence of high-risk esophageal varices	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding event happen	Incidence of hemorrhagic events	1 year
bleeding event happen	Incidence of hemorrhagic events	2 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Publications and helpful links

General Publications

• Sharma S, Agarwal S. Prospective validation of Baveno VI criteria in virally supressed HBV cirrhosis - more evidence is needed. J Hepatol. 2021 Mar;74(3):758-759. doi: 10.1016/j.jhep.2020.10.007. Epub 2021 Jan 19. No abstract available.
• Wang H, Wen B, Chang X, Wu Q, Wen W, Zhou F, Guo Y, Ji Y, Gu Y, Lai Q, He Q, Li J, Chen J, Hou J. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol. 2021 Mar;74(3):584-592. doi: 10.1016/j.jhep.2020.09.034. Epub 2020 Oct 8.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Esophageal and Gastric Varices; Hypertension, Portal; Varicose Veins
• Other Study ID Numbers: 011

Drug and device information, study documents

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