EUS-guided measurement of portal pressure gradient
EUS Guided Portal-systemic Pressure Gradient Measurement in Patients With Chronic Hepatitis.
This study will test an endoscopic ultrasound (EUS) technique to directly measure portal pressure in people with cirrhosis to see if it can safely and accurately indicate portal hypertension.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT04633356 on ClinicalTrials.gov |
What this trial studies
This phase 1–2 interventional trial uses an endoscopic ultrasound (EUS) approach with a novel device to obtain portal and systemic venous pressures and calculate the portal pressure gradient (PPG). Participants are adults with cirrhosis from chronic hepatitis who meet coagulation and anatomical safety criteria. The procedure aims to offer a direct, less invasive alternative to transjugular hepatic venous pressure gradient (HVPG) measurement and will correlate PPG values with risk of clinical complications. Safety, feasibility, and the relationship between PPG and established clinical outcomes will be recorded.
Who should consider this trial
Good fit: Adults with chronic hepatitis–related cirrhosis who can give informed consent and who do not have Child-Pugh class C, severe coagulopathy, portal vein thrombosis, recent spontaneous bacterial peritonitis, or other anatomical barriers to EUS access.
Not a fit: Patients with Child-Pugh class C liver disease, uncorrected platelet count <50,000, INR >1.5, portal vein thrombosis, prior TIPS or surgical shunt, active GI bleeding, large intervening ascites, portopulmonary hypertension, or cardiac decompensation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the technique could provide a safer, more direct and more accessible way to measure portal pressure and help predict complications of cirrhosis.
How similar studies have performed: Small prior reports have shown EUS-guided portal pressure measurement is feasible, but larger validation studies are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suffering from chronic hepatitis induced cirrhosis * Informed consent available Exclusion Criteria: * Medical * Child-Pugh Class C * Uncorrected platelet count \<50,000 * INR \> 1.5 (natural) * Anatomical * Previous transjugular intrahepatic or surgical portosystemic shunt * Portal vein thrombosis * Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure). * Previous history of spontaneous bacterial peritonitis within the previous three months * Portopulmonary hypertension * Cardiac decompensation * Endoscopically Confirmed Exclusion Criteria * Evidence of active GI bleeding (identified at screening and/or during the endoscopic procedure) * If the volume of ascites in the path of the needle prevents apposition of the gastrointestinal tract and liver. * Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers.
Where this trial is running
Hong Kong, Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong, China (Recruiting)
Study contacts
- Study coordinator: Anthony Y Teoh, FRCSEd
- Email: anthonyteoh@surgery.cuhk.edu.hk
- Phone: 35052956
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.