Liver Cirrhosis, Esophageal and Gastric Varices
Conditions
Keywords
Liver Cirrhosis, Esophageal and Gastric Varices, Subharmonic Aided Pressure Estimation
Brief summary
To evaluate the diagnostic value of the combined model of subharmonic-assisted pressure estimation (SHAPE), liver stiffness (LSM), and platelet count (PLT) for high-risk esophageal and gastric varices (HRV)
Interventions
DIAGNOSTIC_TESTSHAPE
Use an ultrasound probe to scan the liver to locate the portal vein and hepatic vein. In the angiography mode, the portal vein and hepatic vein of the same depth were selected for measurement respectively. Ultrasound contrast agent was injected through the elbow vein to observe the changes of sub-harmonic signals in the portal vein and hepatic vein. Collect the sub-harmonic signal data of the portal vein and hepatic vein, and calculate the difference between the two, that is, the SHAPE gradient.
Sponsors
The First Hospital of Jilin University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The SHAPE operator and the analyst, the LSM operator, and the gastroscopy operator blinded each other (unaware of each other's results and clinical data), and the SHAPE images were independently analyzed by two ultrasound physicians.
Intervention model description
This study proposes for the first time a multimodal model integrating SHAPE, LSM and PLT, aiming to overcome the shortcomings of traditional tools, improve the prediction accuracy of high-risk EGV, and provide a new path for optimizing non-invasive screening strategies.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ① Be at least 18 years old② Clinically diagnosed as liver cirrhosis (based on medical history, physical signs, laboratory tests, imaging or liver biopsy)③ Underwent a gastroscopy④ The informed consent form has been signed
Exclusion criteria
* ① Previous EV bleeding or having received TIPS/ endoscopic treatment.② History of concurrent liver cancer, portal vein thrombosis, and splenectomy.③ Having used drugs that affect platelet count, liver function or coagulation function in the body within one week, and having a recent history of blood product infusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HV-PV (dB) | Within two weeks of admission | The difference in the average harmonic signal between the hepatic vein and the portal vein |
| Measurement of liver stiffness（kPa） | Within two weeks of admission | The patient lies on their back, with their right hand placed behind their head. The right upper limb is fully abducted to expose the intercostal Spaces in the right lobe of the liver. The area usually enclosed by the horizontal line of the xiphoid process, the midline of the right axilla and the lower edge of the rib is taken as the testing area. The probe is vertically and closely attached to the skin, and the measurement position is selected in the intercostal space. |
| blood platelet count（×10⁹／L） | Within two weeks of admission | The peripheral blood of the patient was tested by a conventional blood analyzer to obtain the platelet count. |
| sensitivity and specificity | The one-year period from enrollment to the end of the group | The sensitivity measures the ability of the model to correctly identify patients with HRV (i.e., the true positive rate), and the specificity measures the ability of the model to correctly exclude patients without HRV (i.e., the true negative rate). |
| Positive predictive value (PPV) and negative predictive value (NPV) | The one-year period from enrollment to the end of the group | PPV represents the probability that patients identified as high-risk by the model actually have HRV, while NPV represents the probability that patients identified as low-risk by the model do not actually have HRV |
| AUC | The one-year period from enrollment to the end of the group | Comprehensively reflect the overall discriminative ability of the model under different thresholds |
Countries
China
Contacts
CONTACTDezhi Zhang, doctorate
Outcome results
None listed