Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04210297

Enrollment

245

Registered

2019-12-24

Start date

2018-01-01

Completion date

2021-01-01

Last updated

2021-05-14

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

Conditions

Esophageal and Gastric Varices

Keywords

noninvasive, portal hypertension, radiomics

Brief summary

The aim of the study is to develop and validate a new noninvasive method based on routine examination during clinical practice for predicting high risk esophageal varices in cirrhosis.

Detailed description

Portal hypertension is the main consequence of cirrhosis. Variceal bleeding is the principal and life-threatening complication of portal hypertension. Endoscopic screening is the golden standard to detect esophageal varices. However, endoscopy is limited by its invasiveness, cost and the discomfort it imposes on patients. With the goal of circumventing these disadvantages, we intend to develop an noninvasive method for predicting high risk esophageal varices.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

The inclusion criteria: 1. patients who were diagnosed with liver cirrhosis. 2. patients who underwent the abdominal contrast-enhanced CT examination. 3. patients who received endoscopic screening. 4. patients with written informed consent. The

Exclusion criteria

1. patients who previously underwent endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, partial splenic embolization (PSE), hepatectomy, balloon-occluded retrograde transvenous obliteration, or liver transplantation. 2. patients with liver cancer. 3. patients with severe ascites or hepatic encephalopathy. 4. lacks abdominal contrast-enhanced CT within 1 month of endoscopy.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy	through study completion, up to 2 years	The golden standard is endoscopic examination.Compare the accuracy of the noninvasive model with the endoscopic examination.
sensitivity	through study completion, up to 2 years	the sensitivity of predicting high risk esophageal varices of the noninvasive model.
specificity	through study completion, up to 2 years	the specificity of predicting high risk esophageal varices of the noninvasive model.

Countries

China

Outcome results