EUS-guided Response Assessment to NSBB

Recruiting now · Not applicable

Conditions studied: Portal Hypertension Related to Cirrhosis

In brief

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.

Key facts

Study ID

NCT06513195

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

24

Starts

2024-07-17

Expected to finish

2026-12-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• University Hospital Leuven — Leuven, Vlaams-Brabant, Belgium (enrolling)

Full record on ClinicalTrials.gov

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