Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

Liver Cirrhosis Clinical Trial

Official title:

Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04640350
• Other study ID #: S2020-387-02
• Status: Recruiting
• Start date: December 31, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: January 2021
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Doctor
• Phone: 010-66937981
• Email: yu-jie301[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Gastroesophageal Varices
• Hemorrhage
• Liver Cirrhosis
• Variceal Hemorrhage

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	F index	F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.	baseline
Primary	A index	A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.	baseline
Primary	Spleen stiffness	Spleen stiffness can be available by ultrasound elastography checking.	baseline