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Status unknownNCT04640350Updated Jan 19, 2021

Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography

An observational study in Liver Cirrhosis, Gastroesophageal Varices and Variceal Hemorrhage, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by Chinese PLA General Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Cirrhosis
  • Gastroesophageal Varices
  • Variceal Hemorrhage

Keywords

  • Elasticity Imaging Techniques
  • Ultrasound
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 300 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. F index

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

    Time frame: baseline

  2. A index

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

    Time frame: baseline

  3. Spleen stiffness

    Spleen stiffness can be available by ultrasound elastography checking.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    • Ping Liang, Doctor · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04640350
Lead sponsor
Chinese PLA General Hospital
Responsible party
Ping Liang (Chief physician, Chinese PLA General Hospital) — Principal investigator
First posted
Nov 23, 2020
Start date
Dec 31, 2020
Primary completion
Dec 31, 2022 (estimated)
Completion
May 31, 2023 (estimated)
Last update
Jan 19, 2021

Study contacts

Jie Yu, Doctor
Contact
yu-jie301@hotmail.com
010-66937981
Ping Liang, Doctor
principal investigator · Chinese PLA General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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