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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Varicose Veins

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