Clinical trial NCT02593799: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Esophageal and Gastric Varices
Keywords: Liver cirrhosis
Esophageal and Gastric Varices
Endoscopy
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 363
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis who will firstly undergo the upper gastrointestinal endoscopy.

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.

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.

Primary outcomes:
measure: Correlation of biochemical data with esophageal varices in liver cirrhosis
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anshan
country: China
facility: ANSTEEL Group Hospital
state: Liaoning
city: Anshan
country: China
facility: Shuangshan Hospital of Anshan City
state: Liaoning
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Friendship Hospital of Dalian City
state: Liaoning
city: Dandong
country: China
facility: Central Hospital of Dandong City
state: Liaoning
city: Fushun
country: China
facility: Central Hospital of Fushun City
state: Liaoning
city: Fuxin
country: China
facility: General Hospital of Mining Industry Group Fuxin
state: Liaoning
city: Jinzhou
country: China
facility: First Affiliated Hospital of Liaoning Medical University
state: Liaoning
city: Liaoyang
country: China
facility: General Hospital of Liaoyang City
state: Liaoning
city: Panjing
country: China
facility: Central Hospital of Panjin City
state: Liaoning
city: Panjing
country: China
facility: General Hospital of Liaohe Oil Field
state: Liaoning
city: Shenyang
country: China
facility: Department of Gastroenterology, General Hospital of Shenyang Military Area
state: Liaoning
city: Shenyang
country: China
facility: Central Hospital Affiliated to Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: First Affiliated Hospital of Chinese Medical University
state: Liaoning
city: Shenyang
country: China
facility: No. 1 of Department of Gastroenterology, Liaoning Provincial People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: No. 2 of Department of Gastroenterology, Liaoning Provincial People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of Chinese Medical University
state: Liaoning
Study officials:
affiliation: Department of Gastroenterology, General Hospital of Shenyang Military Area
name: Xiaozhong Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Qi 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.