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OpenTrials
Completed

NCT Number: NCT04210297

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

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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Key information

Conditions

Esophageal and Gastric Varices Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria:

  • patients who were diagnosed with liver cirrhosis.
  • patients who underwent the abdominal contrast-enhanced CT examination.
  • patients who received endoscopic screening.
  • patients with written informed consent.

The exclusion criteria:

  • 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.
  • patients with liver cancer.
  • patients with severe ascites or hepatic encephalopathy.
  • lacks abdominal contrast-enhanced CT within 1 month of endoscopy.

Treatment and study plan

Primary outcomes

  1. Accuracy

    Time frame: through study completion, up to 2 years

    The golden standard is endoscopic examination.Compare the accuracy of the noninvasive model with the endoscopic examination.

  2. sensitivity

    Time frame: through study completion, up to 2 years

    the sensitivity of predicting high risk esophageal varices of the noninvasive model.

  3. specificity

    Time frame: through study completion, up to 2 years

    the specificity of predicting high risk esophageal varices of the noninvasive model.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Jinan Central Hospital

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Dec 24, 2019
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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