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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 : Recruiting
First Posted : November 2, 2015
Last Update Posted : August 2, 2018
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.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study
Study Start Date : December 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


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


Contacts
Contact: Xingshun Qi, M.D. 86-18909881019 xingshunqi@126.com
Contact: Xiaozhong Guo, M.D. guo_xiao_zhong@126.com

Locations
China, Liaoning
ANSTEEL Group Hospital Recruiting
Anshan, Liaoning, China
Contact: Bofan Li    86-13154256666    dirty119@163.com   
Principal Investigator: Bofan Li         
Sub-Investigator: Xiaolin Fu         
Shuangshan Hospital of Anshan City Recruiting
Anshan, Liaoning, China
Contact: Yanping Lu    86-18041242509    luyanpingzhoulin@163.com   
Principal Investigator: Yanping Lu         
First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China
Contact: Yingde Wang    18098875577    albertwyd@163.com   
Principal Investigator: Yingde Wang         
Sub-Investigator: Jingwei Mao         
Friendship Hospital of Dalian City Recruiting
Dalian, Liaoning, China
Contact: Yonghong Sun    86-13190112800    yonghongs@163.com   
Principal Investigator: Yonghong Sun         
Sub-Investigator: Fucheng Wang         
Central Hospital of Dandong City Recruiting
Dandong, Liaoning, China
Contact: Li Cheng    86-13941519155    2027546233@qq.com   
Principal Investigator: Li Cheng         
Sub-Investigator: Xin Jiang         
Central Hospital of Fushun City Recruiting
Fushun, Liaoning, China
Contact: Xu Cui    86-15642018555    fscx2007@163.com   
Principal Investigator: Xu Cui         
Sub-Investigator: Liang Liu         
General Hospital of Mining Industry Group Fuxin Recruiting
Fuxin, Liaoning, China
Contact: Xinping Qiu    15140918879    qiuxinping720303@163.com   
Principal Investigator: Xinping Qiu         
First Affiliated Hospital of Liaoning Medical University Recruiting
Jinzhou, Liaoning, China
Contact: Jing Li    86-15940657929    jz7203@139.com   
Principal Investigator: Jing Li         
General Hospital of Liaoyang City Recruiting
Liaoyang, Liaoning, China
Contact: Guohui Qi    86-15904207888    llqq2929@163.com   
Principal Investigator: Guohui Qi         
Sub-Investigator: Pu Guo         
Central Hospital of Panjin City Recruiting
Panjing, Liaoning, China
Contact: Lijun Wang    86-18204279666    pjwanglijun@163.com   
Principal Investigator: Lijun Wang         
General Hospital of Liaohe Oil Field Recruiting
Panjing, Liaoning, China
Contact: Lixin Zhao    86-15184263366    exhyi@sina.com   
Principal Investigator: Lixin Zhao         
Sub-Investigator: Hongyan Duan         
Department of Gastroenterology, General Hospital of Shenyang Military Area Recruiting
Shenyang, Liaoning, China, 110840
Contact: Xingshun Qi, MD    86-18909881019    xingshunqi@126.com   
Contact: Xiaozhong Guo, MD       guo_xiao_zhong@126.com   
Sub-Investigator: Xu Liu, MD         
Sub-Investigator: Hongyu Li, MD         
Principal Investigator: Xiaozhong Guo, MD         
Central Hospital Affiliated to Shenyang Medical College Recruiting
Shenyang, Liaoning, China
Contact: Xiao Wang    13066567553    wangxiao567553@163.com   
Principal Investigator: Xiao Wang         
Sub-Investigator: Xiaojing Di         
First Affiliated Hospital of Chinese Medical University Recruiting
Shenyang, Liaoning, China
Contact: Yiling Li    86-18040096655    LYL-72@163.com   
Principal Investigator: Yiling Li         
No. 1 of Department of Gastroenterology, Liaoning Provincial People's Hospital Recruiting
Shenyang, Liaoning, China
Contact: Yan Li    13998185169    liyanln100@126.com   
Principal Investigator: Yan Li         
Sub-Investigator: Yan Wang         
No. 2 of Department of Gastroenterology, Liaoning Provincial People's Hospital Recruiting
Shenyang, Liaoning, China
Contact: Ruixue Liu    18740071187    liu_Rui_xue@sina.com   
Principal Investigator: Ruixue Liu         
Shengjing Hospital of Chinese Medical University Recruiting
Shenyang, Liaoning, China
Contact: Mengchun Wang    18940251965    wangmc@sj-hospital.org   
Principal Investigator: Mengchun Wang         
Sub-Investigator: Lin Li         
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
Principal Investigator: Xiaozhong Guo, M.D. Department of Gastroenterology, General Hospital of Shenyang Military Area

Publications:
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: August 2, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
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