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Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04123509
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief Summary:
Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is an unsatisfactory screening test.In this prospective clinical study,we will enroll patients with cirrhosis of various causes, all of whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including liver elastography (LSM) and spleen elastography (SSM). Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis of cirrhosis.At the same time, based on SSM and serum differential protein, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found.

Condition or disease
Gastroesophageal Varices Portal Hypertension

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 616 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis: a Prospective, Single-center Trial
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. high-risk esophageal varices [ Time Frame: 2 years ]
    Incidence of high-risk esophageal varices

Secondary Outcome Measures :
  1. bleeding event happen [ Time Frame: 1 year ]
    Incidence of hemorrhagic events

  2. bleeding event happen [ Time Frame: 2 years ]
    Incidence of hemorrhagic events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cirrhosis of various etiologies

Inclusion Criteria:

  1. The age ranged from 18 to 75 years.
  2. Clinical or pathological diagnosis of cirrhosis;
  3. Electronic gastroscopy is planned;
  4. To agree and sign the informed consent;

Exclusion Criteria:

  1. Hepatocellular carcinoma or other malignant tumors have been or are currently diagnosed;
  2. Orthotopic liver transplantation patients;
  3. Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt;
  4. Pregnant women;
  5. Neurological or psychiatric disorders;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04123509

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Contact: Jinjun Chen, PHD 8618588531001
Contact: Biao Wen 8613320961408

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China, Guangdong
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jinjun Chen, PHD    86-18588531001   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University

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Responsible Party: Nanfang Hospital of Southern Medical University Identifier: NCT04123509     History of Changes
Other Study ID Numbers: 011
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Portal
Esophageal and Gastric Varices
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases