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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

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.

Condition or disease Intervention/treatment
Liver Cirrhosis Esophageal and Gastric Varices Procedure: Endoscopy

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.

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Study Type : Observational
Actual Enrollment : 363 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018


Group/Cohort Intervention/treatment
Patients with esophageal varices
Esophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices.
Procedure: Endoscopy
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.
Procedure: Endoscopy
Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with liver cirrhosis who will firstly undergo the upper gastrointestinal endoscopy.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593799


Locations
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China, Liaoning
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, China, 110840
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
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
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Principal Investigator: Xiaozhong Guo, M.D. Department of Gastroenterology, General Hospital of Shenyang Military Area

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xingshun Qi, Dr., General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT02593799     History of Changes
Other Study ID Numbers: NIPEV-1
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Keywords provided by Xingshun Qi, General Hospital of Shenyang Military Region:
Liver cirrhosis
Esophageal and Gastric Varices
Endoscopy

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Varicose Veins
Esophageal and Gastric Varices
Pathologic Processes
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal