Status:
RECRUITING
EUS-guided Response Assessment to NSBB
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Portal Hypertension Related to Cirrhosis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06513195
Start Date
July 17 2024
End Date
July 1 2026
Last Update
July 26 2024
Active Locations (1)
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1
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium, 3000