Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

• Conditions: Liver Cirrhosis; Gastroesophageal Varices; Variceal Hemorrhage

• Registration Number: NCT04640350
• Lead Sponsor: Chinese PLA General Hospital

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.

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 Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-23
• Study Start: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spleen stiffness	baseline	Spleen stiffness can be available by ultrasound elastography checking.
F index	baseline	F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.
A index	baseline	A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China