Using subharmonic imaging with liver stiffness and platelet count to find high-risk esophageal and gastric varices in people with cirrhosis
The Diagnostic Value of Subharmonic Imaging Technology Combined With Liver Stiffness and Platelet Count for High-risk Esophageal and Gastric Varices in Patients With Liver Cirrhosis
NA · The First Hospital of Jilin University · NCT07151885
This tests whether combining subharmonic-assisted pressure estimation, a liver stiffness measurement, and platelet count can identify adults with liver cirrhosis who have high-risk esophageal or gastric varices.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Hospital of Jilin University (other) |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT07151885 on ClinicalTrials.gov |
What this trial studies
Adults with clinically diagnosed liver cirrhosis who have undergone gastroscopy will receive subharmonic-assisted pressure estimation (SHAPE), a liver stiffness measurement (LSM), and a platelet count (PLT). The results will be combined into a diagnostic model and compared against gastroscopy findings for high-risk varices. Patients with prior variceal bleeding, TIPS, endoscopic variceal therapy, liver cancer, portal vein thrombosis, splenectomy, recent blood product transfusion, or recent drugs affecting platelets are excluded. This is a single-center interventional protocol conducted at The First Hospital of Jilin University in Changchun, China.
Who should consider this trial
Good fit: Adults (18 and older) with clinically diagnosed liver cirrhosis who have had a gastroscopy and can provide informed consent are ideal candidates.
Not a fit: People with prior variceal bleeding, prior TIPS or endoscopic variceal treatment, concurrent liver cancer, portal vein thrombosis, splenectomy, recent blood product transfusion, or recent use of drugs that affect platelets or coagulation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined noninvasive approach could help identify patients at high risk for variceal bleeding and reduce unnecessary diagnostic endoscopies.
How similar studies have performed: Liver stiffness plus platelet count is an established noninvasive approach for variceal risk stratification, but adding subharmonic-assisted pressure estimation is a relatively novel technique with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Changchun, Jilin
- The First Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)
Study contacts
- Study coordinator: Dezhi Zhang, doctorate
- Email: dezhi@jlu.edu.cn
- Phone: 0431-88782190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cirrhosis, Esophageal and Gastric Varices, Subharmonic Aided Pressure Estimation