NCT06316869 Noninvasive Prediction of Portal Hypertension in Cirrhosis Using Sound Touch Viscoelastography
| NCT ID | NCT06316869 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University |
| Condition | Portal Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 216 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2027-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 216 participants in total. It began in 2024-09-02 with a primary completion date of 2027-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this observational study is to investigate and validate the utility of the Sound Touch Viscoelastography(STVi) technique in patients with liver cirrhosis for noninvasive prediction of Portal hypertension (PH). The primary research questions it seeks to address are as follows: * What is the correlation between the liver STVi index and Portal Venous Pressure Gradient (HVPG)? * Is STVi an available tool to non-invasively predict PH in patients with liver cirrhosis? And the effectiveness and practicality of STVi will be validated. * To establish a predictive model for Clinically Significant Portal Hypertension (CSPH) utilizing liver STVi index as the primary indicator. The HVPG is considered as the gold standard in this study and STVi was employed to quantify the STVi index of the liver in patients with liver cirrhosis. Researchers will compare the two patients groups, HVPG≥10 mmHg and HVPG\<10 mmHg, to see the usage of STVi in the noninvasive prediction of PH.
Eligibility Criteria
Inclusion Criteria: * Age older than 18 years. * Clinically diagnosed with cirrhosis. Meeting the diagnostic criteria of the 2019 edition of the "Cirrhosis Diagnosis and Treatment Guidelines": (1) Histology consistent with cirrhosis diagnosis; (2) Endoscopy shows esophageal gastric varices or ectopic varices, excluding non-cirrhotic portal hypertension; (3) Imaging examinations such as ultrasound, LSM, or CT suggest features of cirrhosis or portal hypertension: such as splenomegaly, portal vein ≥1.3 cm, LSM measurements meeting diagnostic thresholds for cirrhosis of different etiologies; (4) In the absence of histology, endoscopy, or imaging examinations, the following abnormal indicators suggest the presence of cirrhosis (must meet 2 of the 4 criteria): a. PLT \<100×10\^9/L, with no other explanations; b. Serum ALB \<35 g/L, excluding malnutrition or other causes such as renal disease; c. INR \>1.3 or prolonged PT (discontinuation of thrombolytics or anticoagulants for \>7 days); d. AST/PLT ratio index (APRI): Adult APRI score \>2, with attention to the influence of hepatotoxic drugs and other factors on APRI. * Planning to undergo HVPG testing and meeting the indications for HVPG testing in the "Chinese Expert Consensus on the Clinical Application of Hepatic Venous Pressure Gradient (2018 edition)" : (1) Assessing the efficacy of drug therapy for primary and secondary prevention of esophageal gastric variceal bleeding; (2) Predicting the risk of esophageal gastric variceal bleeding and guiding treatment plan selection; (3) Predicting the risk, degree of progression, and clinical prognosis of decompensated events in cirrhosis; (4) Evaluating the efficacy of related new drugs; (5) Evaluating the accuracy of related non-invasive techniques; (6) Diagnosis and differential diagnosis of portal hypertension types. * Able to understand and voluntarily sign a written informed consent form. Exclusion Criteria: * Post-TIPS procedure; * Post-hepatectomy splenectomy; * Hepatic malignancy; * Portal vein thrombosis; * Individuals with severe cardiac, pulmonary, hepatic, or renal dysfunction; * Pregnant and postpartum women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06316869 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Portal Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06316869 currently recruiting?
Yes, NCT06316869 is actively recruiting participants. Contact the research team at dcxshvip@wmu.edu.cn for enrollment information.
Where is the NCT06316869 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT06316869 clinical trial?
NCT06316869 is sponsored by First Affiliated Hospital of Wenzhou Medical University. The trial plans to enroll 216 participants.