Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

January 13, 2021 updated by: Ping Liang, Chinese PLA General Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with liver cirrhosis and the gastroscopy is in line with the indications of portal hypertension.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
F index
Time Frame: baseline
F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.
baseline
Spleen stiffness
Time Frame: baseline
Spleen stiffness can be available by ultrasound elastography checking.
baseline
A index
Time Frame: baseline
A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2020-387-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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