EUS-guided Response Assessment to NSBB

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

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

Conditions2

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