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EUS-guided Response Assessment to NSBB

RecruitingNAAges 18 Years - 80 YearsAllUniversitaire Ziekenhuizen KU Leuven
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • endoscopic ultrasound-guided portal pressure measurement
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Where

1 site
University Hospital Leuven
Leuven, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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