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National Endoscopic ultrasound portal pressure gradient registry

National Endoscopic ultrasound portal pressure gradient registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000031662
Enrollment
3
Registered
2023-01-12
Start date
2022-09-02
Completion date
Unknown
Last updated
2023-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Endoscopic ultrasound-portal pressure gradient (EUS-PPG) is a novel therapeutic goods administration (TGA) -approved alternative to hepatic venous pressure gradient (HVPG) that has been shown in pilot studies to be safe and technically successful for the evaluation and determination of portal hypertension. EUS-PPG can be performed simultaneously with routine variceal surveillance and can be repeated to provide longitudinal HVPG measurements. Data regarding use in clinical practice is limited. This prospective registry seeks to evaluate the clinical utility of EUS-PPG assessment across multiple tertiary centres. Aims: to evaluate the feasibility and utility of EUS-PPG in clinical practice, safety, clinical applications and the potential for EUS-PPG data to inform clinical management. Correlate EUS-PPG measurements with longitudinal risk of liver-related events, and with a range of non-invasive biomarkers and clinical findings.

Interventions

During an endoscopic ultrasound procedure the portal pressure gradient is measured. Elevation of the portal pressure gradient assists in diagnosis and prognosis of cirrhosis. Hepatic venous pressure gradient (HVPG) is the gold standard for evaluating the presence and severity of portal hypertension (PHTN). HVPG >10 mmHg defines clinically significant Portal hypertension, as this critical threshold predicts for increased risk of decompensation events, including decompensation following liver rese

During an endoscopic ultrasound procedure the portal pressure gradient is measured. Elevation of the portal pressure gradient assists in diagnosis and prognosis of cirrhosis. Hepatic venous pressure gradient (HVPG) is the gold standard for evaluating the presence and severity of portal hypertension (PHTN). HVPG >10 mmHg defines clinically significant Portal hypertension, as this critical threshold predicts for increased risk of decompensation events, including decompensation following liver resection, and death.Endoscopic ultrasound-portal pressure gradient (EUS-PPG) is a novel TGA-approved alternative to HVPG that has been shown in pilot studies to be safe and technically successful for the evaluation and determination of PHTN. EUS-PPG can be performed simultaneously with routine variceal surveillance and can be repeated to provide longitudinal HVPG measurements. Data regarding use in clinical practice is limited. This prospective registry seeks to evaluate the clinical utility of EUS-PPG assessment across multiple tertiary centres. This is a multi-centre prospective registry designed to collect data relating to clinical EUS-PPG assessment, such that the role for EUS-PPG in PHTN investigation, identification, stratification and management may be better understood. The EUS-PPG procedure takes approximately 30 minutes and will be performed once only. Participants will have routine blood tests prior to enrolling to determine eligibility and baseline comorbid status. There is no future specimens to be collected. Baseline demographical, clinical health data and baseline liver status (Bloods, Child Pugh score, abdominal ultrasound findings, fibroscan, medical examination) is collected at baseline. Procedural data is collected (presence of varices, location, high risk stigmata for bleeding, portal hypertensive gastropathy presence), EUS assessment of Portal and Hepatic veins, measurements of the portal vein and hepatic veins, points of access, technical success, calculation of the PPG, length of procedure time, medications administered, additional procedures required, post procedural recommendations. Complications immediate, immediate post-procedure, adverse events via phone calls at Day 7 and Day 30 There are no questionnaires to be collected by the participant for this registry. Longitudinal clinical data will be collected for up to 5 years on each participant

Sponsors

Royal Brisbane & Women's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All consenting participants having and endoscopic ultrasound - portal pressure gradient (EUS-PPG) assessment will be included in this prospective registry.

Exclusion criteria

No exclusion criteria. All patients who are referred for this intervention will be approached to consent to have their data entered into the Registry.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026