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Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04640350
Enrollment
300
Registered
2020-11-23
Start date
2020-12-31
Completion date
2023-05-31
Last updated
2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Varices, Liver Cirrhosis, Variceal Hemorrhage

Keywords

Elasticity Imaging Techniques, Ultrasound

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.

Interventions

None listed

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
F indexbaselineF index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.
A indexbaselineA index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.
Spleen stiffnessbaselineSpleen stiffness can be available by ultrasound elastography checking.

Countries

China

Contacts

Primary ContactJie Yu, Doctor
yu-jie301@hotmail.com010-66937981

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026