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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04123509

Enrollment

616

Registered

2019-10-11

Start date

2019-04-09

Completion date

2021-01-31

Last updated

2019-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Varices, Portal Hypertension

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
bleeding event happen	1 year	Incidence of hemorrhagic events

Countries

China

Contacts

Primary ContactJinjun Chen, PHD

chjj@smu.edu.cn8618588531001

Backup ContactBiao Wen

jevine521219@outlook.com8613320961408

Outcome results