Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

NCT04640350 | Unknown

• 1 other identifier: S2020-387-02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Gastroesophageal Varices; Variceal Hemorrhage

Keywords

Elasticity Imaging Techniques; Ultrasound

Outcome Measures

Primary Outcomes (3)

• F index

  F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.

  baseline

• A index

  A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.

  baseline

• Spleen stiffness

  Spleen stiffness can be available by ultrasound elastography checking.

  baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ping Liang, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, Doctor

CONTACT

010-66937981; yu-jie301@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 23, 2020
• Study Start: December 31, 2020
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

CN (1)