Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study

February 1, 2019 updated by: Xingshun Qi, General Hospital of Shenyang Military Region
Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding. The investigators' recent systematic review evaluated the diagnostic accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex scores in predicting the presence of esophageal varices in liver cirrhosis. However, their diagnostic accuracy was low to moderate. Further study is warranted to establish a reliable score to predict the presence of high-risk esophageal varice in liver cirrhosis.

Study Type

Observational

Enrollment (Actual)

363

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Anshan, Liaoning, China
        • ANSTEEL Group Hospital
      • Anshan, Liaoning, China
        • Shuangshan Hospital of Anshan City
      • Dalian, Liaoning, China
        • First Affiliated Hospital of Dalian Medical University
      • Dalian, Liaoning, China
        • Friendship Hospital of Dalian City
      • Dandong, Liaoning, China
        • Central Hospital of Dandong City
      • Fushun, Liaoning, China
        • Central Hospital of Fushun City
      • Fuxin, Liaoning, China
        • General Hospital of Mining Industry Group Fuxin
      • Jinzhou, Liaoning, China
        • First Affiliated Hospital of Liaoning Medical University
      • Liaoyang, Liaoning, China
        • General Hospital of Liaoyang City
      • Panjing, Liaoning, China
        • Central Hospital of Panjin City
      • Panjing, Liaoning, China
        • General Hospital of Liaohe Oil Field
      • Shenyang, Liaoning, China, 110840
        • Department of Gastroenterology, General Hospital of Shenyang Military Area
      • Shenyang, Liaoning, China
        • Central Hospital Affiliated to Shenyang Medical College
      • Shenyang, Liaoning, China
        • First Affiliated Hospital of Chinese Medical University
      • Shenyang, Liaoning, China
        • No. 1 of Department of Gastroenterology, Liaoning Provincial People's Hospital
      • Shenyang, Liaoning, China
        • No. 2 of Department of Gastroenterology, Liaoning Provincial People's Hospital
      • Shenyang, Liaoning, China
        • Shengjing Hospital of Chinese Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with liver cirrhosis who will firstly undergo the upper gastrointestinal endoscopy.

Description

Inclusion Criteria:

  1. A diagnosis of liver cirrhosis.
  2. Age and sex are not limited.
  3. Etiology of liver cirrhosis is not limited.
  4. Routine laboratory data.
  5. Upper gastrointestinal endoscopy.

Exclusion Criteria:

  1. Non-cirrhotic portal hypertension.
  2. Malignancy.
  3. Absent laboratory data.
  4. A previous diagnosis of esophageal varices.
  5. A previous history of variceal bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with esophageal varices
Esophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices.
Procedure: Endoscopy
Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.
Patients without esophageal varices
Patients without esophageal varices were divided into patients without "any grade" or "high-risk" varices.
Procedure: Endoscopy
Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of biochemical data with esophageal varices in liver cirrhosis
Time Frame: 18 months
The investigators firstly calculated the significant factors associated with the presence of esophageal varices, and then developed a score to predict the presence of esophageal varices in liver cirrhosis.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Investigators

  • Principal Investigator: Xiaozhong Guo, M.D., Department of Gastroenterology, General Hospital of Shenyang Military Area

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2015

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (ESTIMATE)

November 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPEV-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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