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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal and Gastric Varices

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Training cohort

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

No interventions assigned to this group

Internal validation cohort

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

No interventions assigned to this group

External validation cohort

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

No interventions assigned to this group

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No