Assessing portal pressure response to beta-blockers using endoscopic ultrasound

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.