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

NCT ID: NCT02593799

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Liver Cirrhosis Esophageal and Gastric Varices

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with esophageal varices

Esophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices.

Endoscopy

Intervention Type PROCEDURE

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.

Endoscopy

Intervention Type PROCEDURE

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

Interventions

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Endoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Shenyang Military Region

OTHER

Sponsor Role lead

Responsible Party

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Xingshun Qi

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaozhong Guo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, General Hospital of Shenyang Military Area

Locations

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ANSTEEL Group Hospital

Anshan, Liaoning, China

Site Status

Shuangshan Hospital of Anshan City

Anshan, Liaoning, China

Site Status

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

Friendship Hospital of Dalian City

Dalian, Liaoning, China

Site Status

Central Hospital of Dandong City

Dandong, Liaoning, China

Site Status

Central Hospital of Fushun City

Fushun, Liaoning, China

Site Status

General Hospital of Mining Industry Group Fuxin

Fuxin, Liaoning, China

Site Status

First Affiliated Hospital of Liaoning Medical University

Jinzhou, Liaoning, China

Site Status

General Hospital of Liaoyang City

Liaoyang, Liaoning, China

Site Status

Central Hospital of Panjin City

Panjing, Liaoning, China

Site Status

General Hospital of Liaohe Oil Field

Panjing, Liaoning, China

Site Status

Department of Gastroenterology, General Hospital of Shenyang Military Area

Shenyang, Liaoning, China

Site Status

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, China

Site Status

First Affiliated Hospital of Chinese Medical University

Shenyang, Liaoning, China

Site Status

No. 1 of Department of Gastroenterology, Liaoning Provincial People's Hospital

Shenyang, Liaoning, China

Site Status

No. 2 of Department of Gastroenterology, Liaoning Provincial People's Hospital

Shenyang, Liaoning, China

Site Status

Shengjing Hospital of Chinese Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 26496312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26159631 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31093864 (View on PubMed)

Other Identifiers

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NIPEV-1

Identifier Type: -

Identifier Source: org_study_id

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