| NCT ID | NCT06513195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Portal Hypertension Related to Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-07-17 with a primary completion date of 2026-12.
⚠ 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 goal of this clinical trial is to learn if endoscopic ultrasound (EUS)-guided portal pressure measurement can determine 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 measurement before start of Carvedilol en after three months of treatment. EUS-guided measurements will be paired with transjugular hepatic venous pressure gradient (HVPG) measurement as well as non-invasive tests for assessment of portal hypertension.
Eligibility 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
Contact & Investigator
Schalk van der Merwe, MD, PhD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT06513195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Portal Hypertension Related to Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513195 currently recruiting?
Yes, NCT06513195 is actively recruiting participants. Contact the research team at emma.vanderschueren@uzleuven.be for enrollment information.
Where is the NCT06513195 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06513195 clinical trial?
NCT06513195 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Schalk van der Merwe, MD, PhD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 24 participants.