RecruitingNot Applicable

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

China380 participantsStarted 2025-08-31

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HV-PV (dB)

Timeframe: Within two weeks of admission

Measurement of liver stiffness（kPa）

Timeframe: Within two weeks of admission

blood platelet count（×10⁹／L）

Timeframe: Within two weeks of admission

sensitivity and specificity

Timeframe: The one-year period from enrollment to the end of the group

Positive predictive value (PPV) and negative predictive value (NPV)

Timeframe: The one-year period from enrollment to the end of the group

AUC

Timeframe: The one-year period from enrollment to the end of the group

Trial details

NCT IDNCT07151885

SponsorThe First Hospital of Jilin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Dezhi Zhang, doctorate

0431-88782190 dezhi@jlu.edu.cn

View on ClinicalTrials.gov More Liver Cirrhosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

HV-PV (dB)

Timeframe: Within two weeks of admission

Measurement of liver stiffness（kPa）

Timeframe: Within two weeks of admission

blood platelet count（×10⁹／L）

Timeframe: Within two weeks of admission

sensitivity and specificity

Timeframe: The one-year period from enrollment to the end of the group

Positive predictive value (PPV) and negative predictive value (NPV)

Timeframe: The one-year period from enrollment to the end of the group

AUC

Timeframe: The one-year period from enrollment to the end of the group