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NCT07877298
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Conditions: Portal Hypertension, Chronic Liver Disease, Liver Cirrhosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: University Hospital Muenster
Location: UZ Leuven Leuven
Summary
This prospective multicentre observational reliability study will determine how much a repeated endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement differs from the first measurement in the same patient during the same procedural session. Each participant will undergo two complete EUS-PPG measurement sets using an identical 22-gauge measurement setup. The study will quantify within-session repeatability when the same expert performs both sets and inter-operator reproducibility when different operators perform the sets.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Clinical indication for EUS-guided portal pressure gradient measurement established independently of the study
* Written informed consent, including consent for the additional measurement set
Exclusion Criteria:
* Contraindication to endoscopy, sedation, or endosonography-guided vascular puncture
* Non-correctable coagulation disorder
* Hemodynamic instability at the time of the procedure
* Any intervention between the two measurement sets that may alter portal pressure, including fluid administration beyond maintenance requirements, vasoactive substances, paracentesis, or variceal band ligation
* Technically non-evaluable first measurement set
* Pregnancy or breastfeeding
* Inability to provide informed consent
Source: ClinicalTrials.gov (NCT07877298). StuddyBuddy aggregates publicly available trial information.