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NCT04210297 Clinical Trial

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

Esophageal and Gastric Varices Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04210297
Other study ID # LinMaxwell2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date January 1, 2021

Study information
Verified date May 2021
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date January 1, 2021
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Gastroenterology,Qilu Hospital,Shandong University Jinan Shandong

Sponsors (2)
Lead Sponsor Collaborator
Qilu Hospital of Shandong University Jinan Central Hospital

Country where clinical trial is conducted

China, 

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