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

Shandong University

Status: Completed

Conditions: Esophageal and Gastric Varices

Study type: Observational

Funder types: Other

Identifiers

NCT04210297

LinMaxwell2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

245 participants in 3 patient groups

Training cohort

Description:

Training cohort consists of the cirrhotic patients who collected from January 2018 to December 2019 of Qilu Hospital retrospectively.

Internal validation cohort

Description:

Internal validation cohort consists of the cirrhotic patients who enrolled from January 2020 of Qilu Hospital prospectively.

External validation cohort

Description:

External validation cohort consists of the cirrhotic patients who enrolled from January 2020 in Jinan Central Hospital prospectively.