EUS-guided Response Assessment to NSBB

Last updated: July 25, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Williams Syndrome

Scar Tissue

Treatment

endoscopic ultrasound-guided portal pressure measurement

Clinical Study ID

NCT06513195
s67433
  • Ages 18-80
  • All Genders

Study 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

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 pressuremeasurements as per protocol.

Exclusion

Exclusion Criteria:

General criteria

  • Patient is <18 or >80 years of age

  • Patient is pregnant, breast-feeding or planning to become pregnant during the courseof the study

  • Patient is unwilling or unable to sign the informed consent

  • Patients in whom general anesthesia or endoscopic procedures are contraindicatedMedical criteria

  • Patients with cirrhosis and HCC Portopulmonary hypertension Portal or splanchnicvenous 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, includingbut 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 hepaticvein or intrahepatic portion of the portal vein, including anatomy that predisposesto 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

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: endoscopic ultrasound-guided portal pressure measurement
Phase:
Study Start date:
July 17, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • University Hospital Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

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