RecruitingNot ApplicableNCT06513195

EUS-guided Response Assessment to NSBB

Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

24 participants

Start Date

Jul 17, 2024

Study Type

INTERVENTIONAL

Conditions

Portal Hypertension Related to Cirrhosis

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 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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria19

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

Interventions

PROCEDUREendoscopic ultrasound-guided portal pressure measurement

The portal pressure gradient will be determined by endoscopic ultrasound-guided pressure measurement in the hepatic vein and the portal vein. The gradient will be calculated by substracting the hepatic vein pressure from the portal vein pressure.