EUS-guided Response Assessment to NSBB
Recruiting · NCT06513195 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitaire Ziekenhuizen KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
endoscopic ultrasound-guided portal pressure measurement
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- University Hospital Leuven - Leuven, Vlaams-Brabant, Belgium