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Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04640350
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

Study Description
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Brief Summary:
Through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis.

Condition or disease
Liver Cirrhosis Gastroesophageal Varices Variceal Hemorrhage

Detailed Description:

Firstly,the combi-elastography technique developed by HITACHI uses the method of multi-index and multi-parameter to evaluate the liver stiffness and spleen stiffness comprehensively.

And then,this prospective study is designed to follow up patients with cirrhosis for a period of 12 months, summarize and analyze the warning index of bleeding in patients with cirrhosis,so as to provide a new and valuable technique for clinical diagnosis.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography
Actual Study Start Date : December 31, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. F index [ Time Frame: baseline ]
    F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.

  2. A index [ Time Frame: baseline ]
    A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.

  3. Spleen stiffness [ Time Frame: baseline ]
    Spleen stiffness can be available by ultrasound elastography checking.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with liver cirrhosis and the gastroscopy is in line with the indications of portal hypertension.
Criteria

Inclusion Criteria:

  • 18-80 years old, no gender limit;
  • The clinical diagnosis is in line with patients with liver cirrhosis caused by chronic hepatitis B, and the gastroscopy is in line with the indications of portal hypertension;
  • Gastroscopy needs to provide the degree of gastroesophageal varices;
  • Sign the informed consent form.

Exclusion Criteria:

  • Patients with cirrhosis and portal hypertension because of other causes or combined with other causes(such as viral hepatitis other than hepatitis B,Autoimmune liver disease, alcoholic liver disease, metabolism-related fatty liver disease, etc.)
  • Patients with a history of spleen-related operations, such as splenectomy, splenic embolism;
  • Patients undergoing portosystemic shunt or TIPS;
  • Isolated esophageal venous tumor and its bleeding patients;
  • History of upper gastrointestinal tumor or bleeding from gastric ulcer , etc;
  • Those with serious diseases of other systems that cannot cooperate with elastography examination, such as heart failure, renal failure, mental illness, etc;
  • Ascites before liver and spleen result unable to complete elasticity examination;
  • Pregnant patients.
Contacts and Locations
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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): NCT04640350


Contacts
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Contact: Jie Yu, Doctor 010-66937981 yu-jie301@hotmail.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Ping Liang, Doctor         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Ping Liang, Doctor Chinese PLA General Hospital
More Information
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Responsible Party: Ping Liang, Chief physician, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04640350    
Other Study ID Numbers: S2020-387-02
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ping Liang, Chinese PLA General Hospital:
Elasticity Imaging Techniques
Ultrasound
Additional relevant MeSH terms:
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Liver Cirrhosis
Hemorrhage
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases