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

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Completed
CT.gov ID
NCT04210297
Collaborator
Jinan Central Hospital (Other)
245
Enrollment
1
Location
36
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    245 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Oct 1, 2019
    Actual Study Completion Date :
    Jan 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Training cohort

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

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy [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 [through study completion, up to 2 years]

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

    3. specificity [through study completion, up to 2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology,Qilu Hospital,Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Qilu Hospital of Shandong University
    • Jinan Central Hospital

    Investigators

    • Principal Investigator: Yanjing Gao, PhD.MD, Qilu Hospital of Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanjing Gao, Clinical Professor, Qilu Hospital of Shandong University
    ClinicalTrials.gov Identifier:
    NCT04210297
    Other Study ID Numbers:
    • LinMaxwell2018
    First Posted:
    Dec 24, 2019
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Yanjing Gao, Clinical Professor, Qilu Hospital of Shandong University
    noninvasive
    portal hypertension
    radiomics
    Additional relevant MeSH terms:
    Esophageal and Gastric Varices
    Varicose Veins

    Study Results

    No Results Posted as of May 14, 2021