Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study
1 other identifier
observational
363
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 30, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 4, 2019
February 1, 2019
3.7 years
October 30, 2015
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Patients with esophageal varices
Esophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices.
Patients without esophageal varices
Patients without esophageal varices were divided into patients without "any grade" or "high-risk" varices.
Interventions
Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.
Eligibility Criteria
Patients with liver cirrhosis who will firstly undergo the upper gastrointestinal endoscopy.
You may qualify if:
- A diagnosis of liver cirrhosis.
- Age and sex are not limited.
- Etiology of liver cirrhosis is not limited.
- Routine laboratory data.
- Upper gastrointestinal endoscopy.
You may not qualify if:
- Non-cirrhotic portal hypertension.
- Malignancy.
- Absent laboratory data.
- A previous diagnosis of esophageal varices.
- A previous history of variceal bleeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
Department of Gastroenterology, General Hospital of Shenyang Military Area
Shenyang, Liaoning, 110840, 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
Shenyang, Liaoning, China
Related Publications (3)
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.
PMID: 26496312BACKGROUNDQi 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.
PMID: 26159631BACKGROUNDQi X, Li Y, Wang R, Lin L, Li J, Wang L, Zheng S, Sun Y, Zhao L, Fu X, Wang M, Qiu X, Deng H, Hong C, Li Q, Li H, Guo X. Liaoning Score for Prediction of Esophageal Varices in Cirrhotic Patients Who Had Never Undergone Endoscopy: A Multicenter Cross-Sectional Study in Liaoning Province, China. Adv Ther. 2019 Aug;36(8):2167-2178. doi: 10.1007/s12325-019-00967-w. Epub 2019 May 15.
PMID: 31093864DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaozhong Guo, M.D.
Department of Gastroenterology, General Hospital of Shenyang Military Area
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
October 30, 2015
First Posted
November 2, 2015
Study Start
May 1, 2015
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
February 4, 2019
Record last verified: 2019-02