Assessing portal pressure response to beta-blockers using endoscopic ultrasound
Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension
NA · Universitaire Ziekenhuizen KU Leuven · NCT06513195
This study is testing if using endoscopic ultrasound to measure portal pressure can help doctors see how well beta-blockers work for people with cirrhosis and high blood pressure in the liver.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06513195 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether endoscopic ultrasound (EUS)-guided portal pressure measurement can effectively assess the treatment response to non-selective beta-blockers (NSBB) in patients with cirrhosis and clinically significant portal hypertension (CSPH). Participants will undergo EUS-guided portal pressure measurements before starting treatment with Carvedilol and again after three months. These measurements will be compared with transjugular hepatic venous pressure gradient (HVPG) assessments and non-invasive tests to provide a comprehensive evaluation of portal hypertension management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with compensated cirrhosis and suspected clinically significant portal hypertension who have not yet started NSBB therapy.
Not a fit: Patients with conditions such as hepatocellular carcinoma, portopulmonary hypertension, or those who have undergone prior liver transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective management of portal hypertension in patients with cirrhosis, improving their overall health outcomes.
How similar studies have performed: While the use of EUS for portal pressure measurement is established, this specific approach to assess treatment response to NSBB in cirrhosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a clinical and/or pathological diagnosis of compensated cirrhosis. * Patients with suspicion of CSPH and thus indication for NSBB treatment. * Patients not yet on NSBB therapy. * Patients willing and able to undergo repeated HVPG and EUS-guided pressure measurements as per protocol. Exclusion Criteria: General criteria * Patient is \<18 or \>80 years of age * Patient is pregnant, breast-feeding or planning to become pregnant during the course of the study * Patient is unwilling or unable to sign the informed consent * Patients in whom general anesthesia or endoscopic procedures are contraindicated Medical criteria * Patients with cirrhosis and HCC Portopulmonary hypertension Portal or splanchnic venous thrombosis Prior TIPS Prior liver transplantation * Non-cirrhotic portal hypertension or pre-sinusoidal liver disease * Cholestatic liver disease with total bilirubin \>3 mg/dl * Previous total or partial splenectomy * Known infection that is not controlled by medical intervention * Patients with contraindications for non-selective beta-blocker therapy, including but not limited to the following baseline vital signs: Systolic BP \<100 mmHg HR \<50 bpm * Patients with reduced life expectancy described by an ASA score of 4 or 5 * INR \>1.7 or platelet count \<50.000 per mm3 * eGFR \<50 ml/min/1.73m2 (CKD-EPI formula) Anatomical criteria * Anatomical abnormalities that prevent access via EUS-guided puncture to the hepatic vein or intrahepatic portion of the portal vein, including anatomy that predisposes to difficult to reach puncture sites or an inadequate needle angle. * Visualization of ascites interposing the puncture tract on EUS * Diagnosis of portal vein thrombosis during EUS * Evidence of active gastrointestinal bleeding during EUS
Where this trial is running
Leuven, Vlaams-Brabant
- University Hospital Leuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)
Study contacts
- Principal investigator: Schalk van der Merwe, MD, PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Emma Vanderschueren, MD
- Email: emma.vanderschueren@uzleuven.be
- Phone: 0032 16 345918
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.
Conditions: Portal Hypertension Related to Cirrhosis, portal hypertension, EUS-PPG, HVPG, cirrhosis, non-selective beta blockers