Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment380 (estimated)
SponsorThe First Hospital of Jilin University
Academic / other
Locations1 site (Changchun, Jilin)
StatusRecruiting
StartedAugust 31, 2025
Main results expectedJuly 31, 2028
Study endsJuly 31, 2028
Registry record updatedMay 5, 2026
Trial IDNCT07151885 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.