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

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ClinicalTrials.gov Identifier: NCT02593799
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Xingshun Qi, General Hospital of Shenyang Military Region

Tracking Information
First Submitted Date October 30, 2015
First Posted Date November 2, 2015
Last Update Posted Date February 4, 2019
Actual Study Start Date May 1, 2015
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02593799 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study
Official Title Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study
Brief Summary 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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with liver cirrhosis who will firstly undergo the upper gastrointestinal endoscopy.
Condition
  • Liver Cirrhosis
  • Esophageal and Gastric Varices
Intervention Procedure: Endoscopy
Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.
Study Groups/Cohorts
  • Patients with esophageal varices
    Esophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices.
    Intervention: Procedure: Endoscopy
  • Patients without esophageal varices
    Patients without esophageal varices were divided into patients without "any grade" or "high-risk" varices.
    Intervention: Procedure: Endoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2019)
363
Original Estimated Enrollment
 (submitted: October 30, 2015)
1000
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02593799
Other Study ID Numbers NIPEV-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Xingshun Qi, General Hospital of Shenyang Military Region
Study Sponsor General Hospital of Shenyang Military Region
Collaborators Not Provided
Investigators
Principal Investigator: Xiaozhong Guo, M.D. Department of Gastroenterology, General Hospital of Shenyang Military Area
PRS Account General Hospital of Shenyang Military Region
Verification Date February 2019