Clinical trial NCT06513195: EUS-guided Response Assessment to NSBB
Official title: Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Portal Hypertension Related to Cirrhosis
Keywords: portal hypertension
EUS-PPG
HVPG
cirrhosis
non-selective beta blockers
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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 criteria: 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

Primary outcomes:
measure: EUS-guided response assessment to NSBB in the treatment of CSPH.
timeFrame: Three months
Secondary outcomes:
measure: Correlation of EUS-PPG with HVPG
timeFrame: Three months
measure: Correlation of FHVP with HVP.
timeFrame: Three months
measure: Correlation of PVP with WHVP.
timeFrame: Three months
measure: CSPH assessed via EUS-guided pressure measurement.
timeFrame: Three months
measure: Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB.
timeFrame: Three months
measure: Safety of repeated EUS-PPG
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Schalk van der Merwe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: