Comparing HVPG and endoscopic ultrasound portal pressure measurements
Hepatic Venous Pressure Gradient Versus Endoscopic Ultrasound-Guided Portal Pressure Gradient - Comparative Analysis
This study will test whether an endoscopic ultrasound method (EUS-PPG) gives the same portal pressure readings as the standard hepatic venous pressure gradient (HVPG) in adults who need portal pressure measurement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Military University Hospital, Prague Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Prague, Bohemia and 1 other locations) |
| Trial ID | NCT07424963 on ClinicalTrials.gov |
What this trial studies
This interventional study compares portal pressure readings from the standard transjugular hepatic venous pressure gradient (HVPG) technique with readings obtained by endoscopic ultrasound-guided portal pressure gradient (EUS-PPG). Participants indicated for HVPG will first have HVPG measured while conscious by one operator, then HVPG repeated under anesthesia by a second operator blinded to the initial values, and finally EUS-PPG will be performed by an endoscopist blinded to prior measurements. The primary aim is to determine whether EUS-PPG provides equivalent gradient accuracy to HVPG. Results could clarify whether EUS-PPG is a reliable alternative for clinical decision-making in portal hypertension.
Who should consider this trial
Good fit: Adults 18–75 years with a clinical indication for HVPG measurement or transjugular liver biopsy for chronic advanced liver disease are ideal candidates for this study.
Not a fit: Patients with portal vein thrombosis, cavernoma, severe comorbidities, pregnancy, uncontrolled coagulopathy, Grade 3 ascites, altered upper GI anatomy, or who cannot stop anticoagulation are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, EUS-PPG could become a reliable alternative way to measure portal pressure that might be performed during endoscopy and broaden access to accurate portal pressure data.
How similar studies have performed: Small single-center studies and pilot series have shown promising agreement between EUS-PPG and HVPG, but larger comparative validations are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years at the time of enrollment; signed informed consent * Clinical indication for HVPG measurement and/or transjugular liver biopsy for chronic advanced liver disease Exclusion Criteria: * Severe co-morbidities (e.g., advanced chronic heart failure, chronic renal insufficiency stage 4 and above, long-term poorly compensated diabetes mellitus with severe complications) * Pregnancy * Estimated patient non-compliance and/or not signing of the informed consent * Documented iodine contrast dye allergy * Presence of portal vein thrombosis or cavernomatous transformation of portal vein or hepatic vein obstruction * Ascites Grade 3 * Biliary obstruction * Anticoagulation or antiplatelet therapy, which cannot be discontinued * INR \> 1.5 and/or platelet count \< 50,000/µl * Hepatocellular carcinoma in the left lobe of the liver * Surgically altered upper gastrointestinal tract anatomy * State after transjugular intrahepatic portosystemic shunt * State after liver transplantation
Where this trial is running
Prague, Bohemia and 1 other locations
- Military University Hospital Prague — Prague, Bohemia, Czechia (Recruiting)
- Ikem — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Petr Hříbek, MD, PhD — Military University Hospital, Prague
- Study coordinator: Petr Hříbek, MD, PhD
- Email: petr.hribek@uvn.cz
- Phone: +420973203065
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.