Using subharmonic imaging with liver stiffness and platelet count to find high-risk esophageal and gastric varices in people with cirrhosis
Official title: 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
Run by The First Hospital of Jilin University · NCT07151885 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 380 (estimated) |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Status | Recruiting |
| Started | August 31, 2025 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07151885 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18 and older) with clinically diagnosed liver cirrhosis who have had a gastroscopy and can provide informed consent are ideal candidates.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.