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NCT02593799 Clinical Trial

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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02593799
Other study ID # NIPEV-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2015
Est. completion date December 31, 2018

Study information
Verified date February 2019
Source General Hospital of Shenyang Military Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 363
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopy
Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.

Locations
Country Name City State
China ANSTEEL Group Hospital Anshan Liaoning
China Shuangshan Hospital of Anshan City Anshan Liaoning
China First Affiliated Hospital of Dalian Medical University Dalian Liaoning
China Friendship Hospital of Dalian City Dalian Liaoning
China Central Hospital of Dandong City Dandong Liaoning
China Central Hospital of Fushun City Fushun Liaoning
China General Hospital of Mining Industry Group Fuxin Fuxin Liaoning
China First Affiliated Hospital of Liaoning Medical University Jinzhou Liaoning
China General Hospital of Liaoyang City Liaoyang Liaoning
China Central Hospital of Panjin City Panjing Liaoning
China General Hospital of Liaohe Oil Field Panjing Liaoning
China Central Hospital Affiliated to Shenyang Medical College Shenyang Liaoning
China Department of Gastroenterology, General Hospital of Shenyang Military Area 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 Shenyang Liaoning

Sponsors (1)
Lead Sponsor Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (2)

Deng H, Qi X, Guo X. Diagnostic Accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex Scores in Predicting the Presence of Esophageal Varices in Liver Cirrhosis: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2015 Oct;94(42):e1795. doi: 10.1097/MD.0000000000001795. Review. Erratum in: Medicine (Baltimore). 2016 Feb;95(5):1. — View Citation

Qi X, Guo X, Li H, Liu X, Deng H. Knowledge about non-invasive diagnostic tests for varices in liver cirrhosis: A questionnaire survey to the Gastroenterology Branch of the Liaoning Medical Association, China. Gastroenterol Rep (Oxf). 2016 May;4(2):141-7. doi: 10.1093/gastro/gov031. Epub 2015 Jul 9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of biochemical data with esophageal varices in liver cirrhosis 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
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