An observational study in Portal Hypertension, Chronic Liver Disease and Liver Cirrhosis, sponsored by University Hospital Muenster. Not yet recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University Hospital Muenster · Observational
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.
Consecutive adults with an independently established clinical indication for EUS-PPG will be enrolled at five centres. The clinically indicated first measurement will be followed by a research-only second complete measurement set during the same sedation episode, without an intervention between sets. After the first set, the system will be flushed, the needle fully withdrawn from the liver, the system recalibrated, and the portal and hepatic veins punctured again for fresh triplicate readings. The interval between sets is targeted at 10 minutes or less. Procedure lists will be cluster-randomised according to examination lists to one of three operator configurations: the same expert performs both sets, two different experts perform the sets, or an expert and a trainee under supervision perform the sets. The order within each pair will be randomised. Clinical decisions will be based exclusively on the first measurement set. Participants will undergo safety follow-up through day 30.
345 studies on the registry are indexed under Hypertension, Portal; 110 are open to participants now.
This study's planned enrollment of 150 is close to the median of 151 across 128 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adult patients with an independently established clinical indication for EUS-guided portal pressure gradient measurement, including patients with and without clinically significant portal hypertension.
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Exclusion Criteria:
Both complete measurement sets are performed by the same expert operator.
Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient Measurement
The two complete measurement sets are performed by two different expert operators, with order randomised.
Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient Measurement
One complete measurement set is performed by an expert and the other by a trainee under direct supervision, with order randomised.
Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient Measurement
During a clinically indicated EUS-PPG procedure, each participant undergoes a second complete EUS-PPG measurement set in the same session. For each set, pressures in a hepatic vein and an intrahepatic portal vein branch are measured in triplicate using the same 22-gauge measurement chain. Before the repeat set, the system is flushed, the needle is fully withdrawn from the liver, the transducer is recalibrated, and the target vessels are independently re-identified and punctured. No treatment or portal-pressure-altering intervention occurs between the two sets.
Within-session repeatability coefficient of EUS-PPG measured by the same expert operator
The repeatability coefficient will be calculated as 2.77 multiplied by the within-subject standard deviation of paired EUS-PPG measurements in the same-expert group. It will be reported in mmHg and as a percentage of the cohort mean, with a 95% confidence interval.
Time frame: During the index EUS-PPG procedure
Inter-operator reproducibility coefficient of EUS-PPG
The reproducibility coefficient will be estimated from paired EUS-PPG differences when different operators perform the two measurement sets and will be reported in mmHg and as a percentage, with a 95% confidence interval.
Time frame: During the index EUS-PPG procedure
Variance components of repeated EUS-PPG measurements
A mixed-effects model using all individual readings will estimate patient-, procedure-list-, operator-, measurement-set-, and reading-level variance components.
Time frame: During the index EUS-PPG procedure
Intraclass correlation coefficient for paired EUS-PPG measurements
Two-way absolute-agreement intraclass correlation coefficients will be reported overall and by operator configuration with 95% confidence intervals.
Time frame: During the index EUS-PPG procedure
Bland-Altman agreement of paired EUS-PPG measurements
Bias and 95% limits of agreement will be calculated overall and separately by operator pairing.
Time frame: During the index EUS-PPG procedure
Discordant classification at portal pressure gradient thresholds of 10 mmHg and 12 mmHg
The proportion of participants whose classification crosses the 10-mmHg or 12-mmHg threshold between the two measurement sets will be reported.
Time frame: During the index EUS-PPG procedure
Procedure-associated adverse events
Adverse events will include bleeding, pain, hemoglobin decrease, sedation-related events, unplanned admission or prolongation of stay, transfusion, and unplanned intervention.
Time frame: From the index procedure through 30 days
Plan to share: Undecided
Start is estimated for Jan 2027; primary completion for Jul 2028, 18 months later.
Of 61 non-industry observational studies under Hypertension, Portal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 256. This study's planned 18 months is below that.
Counting every sponsor, half of 64 studies reached it within 43 months; a quarter within 30 and three quarters within 256.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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