Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000031662
Ethics application status
Approved
Date submitted
14/11/2022
Date registered
12/01/2023
Date last updated
12/01/2023
Date data sharing statement initially provided
12/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
National Endoscopic ultrasound portal pressure gradient registry
Scientific title
National Endoscopic ultrasound portal pressure gradient registry
Secondary ID [1] 308408 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatic disease 328210 0
Condition category
Condition code
Oral and Gastrointestinal 325260 325260 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
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
Intervention code [1] 324861 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333106 0
All participants will undergo an endoscopic assessment of portal hypertension, which includes an endoscopy and EUS. EUS-PPG measurement will be performed by endosonographers trained in EUS-PPG, using the Echotip Ultra device (Cook Medical), which comprises a 25gauge FNA-needle, 90cm non-compressible tubing and a manometer.
Timepoint [1] 333106 0
Baseline -during endoscopic ultrasound (EUS) procedure
Secondary outcome [1] 415849 0
Successful portal pressure gradient (PPG) measurement (Yes/No). There is no radiology involved in this procedure. It is a direct sampling method via the use of a 25 gauge needle into the hepatic and portal veins. Able to achieve 3 consecutive attempts to sample the portal pressure, the mean pressure is calculated from the 3 measurements (for each the hepatic and portal veins).
Timepoint [1] 415849 0
Baseline - during endoscopic ultrasound procedure
Secondary outcome [2] 415850 0
Adverse events will be collected at a phone call at day 7 and day 30 post procedure. These are categorised as: Abdominal pain, bleeding, fever, perforation, damage to local structures, anaesthetic complication, other, death.
At these time points it is noted if there has been any hospitalisation and indication/length of stay / intervention required / likelihood related to the PPG measure
Timepoint [2] 415850 0
During procedure (Intraprocedure), Immediately post-procedure, Day 7 and day 30 post procedure.
Secondary outcome [3] 417133 0
Body Mass Index )height determined by stadiometer, and weight determined using balance scales)
Timepoint [3] 417133 0
Baseline at EUS procedure , 6 months and 12 months post-ultrasound procedure
Secondary outcome [4] 417134 0
Routine serum pathology blood tests (as measured by Queensland Pathology parameters- this varies for each item measured)
Timepoint [4] 417134 0
Baseline at EUS procedure , 6 months and 12 months post-ultrasound procedure
Secondary outcome [5] 417135 0
Abdominal imaging (ultrasound imaging and / or cross sectional imaging)
Timepoint [5] 417135 0
Baseline at EUS procedure , 6 months and 12 months post-ultrasound procedure
Secondary outcome [6] 417136 0
Elastography (liver and spleen measured by Fibroscan)
Timepoint [6] 417136 0
Baseline at EUS procedure , 6 months and 12 months post-ultrasound procedure
Secondary outcome [7] 417137 0
Upper gastrointestinal endoscopy results (any new pathology or abnormalities noted at each endoscopy)
Timepoint [7] 417137 0
Baseline at EUS procedure , 6 months and 12 months post-ultrasound procedure
Secondary outcome [8] 417138 0
Child Pugh Score ( a composite score that assesses prognosis of chronic liver disease)
Timepoint [8] 417138 0
Baseline at EUS procedure , 6 months and 12 months post-ultrasound procedure
Secondary outcome [9] 417139 0
MELD score - Model for end stage liver disease (assesses severity of chronic liver disease) - composite score
Timepoint [9] 417139 0
Baseline at EUS procedure , 6 months and 12 months post-ultrasound procedure
Secondary outcome [10] 417140 0
Change in clinical management of the patient's condition initiated on the basis of the EUS-PPG data at baseline -change in pharmacology medication, referral for surgery, interventional radiology procedure or hepatic transplantation
Timepoint [10] 417140 0
Baseline at EUS procedure , 6 months and 12 months post-ultrasound procedure
Secondary outcome [11] 417141 0
Development of hepatic decompensation (evidenced by variceal bleed or ascites or jaundice or hepatic encelopathy or spontaneous bacterial peritonitis or varices needing treatment, de novo carcinoma, referral for hepatic transplantation)
Timepoint [11] 417141 0
Post EUS procedure the following time points: 6 months, 12 months, 18 months, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5 years and 5 years
Secondary outcome [12] 417142 0
Mortality
Timepoint [12] 417142 0
Post EUS procedure the following time points: 6 months, 12 months, 18 months, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5 years and 5 years

Eligibility
Key inclusion criteria
All consenting participants having and endoscopic ultrasound - portal pressure gradient (EUS-PPG) assessment will be included in this prospective registry.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
There is no statistical methods / analysis attached to this prospective registry as it serves as registry of clinical data. This is for clinical data, endoscopic data, and safety data. Descriptive statistics may be employed in the future to evaluate clinical outcomes in relation to the EUS-PPG result. This may measure the longitudinal Model for end-stage liver disease (MELD) and Child Pugh trend, longitudinal liver/spleen stiffness trend and risk of development of de novo GOV, non-GOV varices or VNT.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA,VIC
Recruitment hospital [1] 23557 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 23558 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [3] 23559 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 23561 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 23562 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 38979 0
4029 - Herston
Recruitment postcode(s) [2] 38980 0
3065 - Fitzroy
Recruitment postcode(s) [3] 38981 0
6000 - Perth
Recruitment postcode(s) [4] 38983 0
3128 - Box Hill
Recruitment postcode(s) [5] 38984 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 25134 0
New Zealand
State/province [1] 25134 0
Waikato

Funding & Sponsors
Funding source category [1] 312656 0
Hospital
Name [1] 312656 0
Royal Brisbane & Women's Hospital
Country [1] 312656 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Women's Hospital
Address
Department of Gastroenterology & Hepatology
Level 9 Ned Hanlon building
Butterfield Street, Herston, 4029, Queensland
Country
Australia
Secondary sponsor category [1] 314267 0
None
Name [1] 314267 0
Address [1] 314267 0
Country [1] 314267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311963 0
Royal Brisbane & Women's Hospital
Ethics committee address [1] 311963 0
Ethics committee country [1] 311963 0
Australia
Date submitted for ethics approval [1] 311963 0
20/12/2021
Approval date [1] 311963 0
26/04/2022
Ethics approval number [1] 311963 0
HREC/2021/QRBW/77979

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122986 0
Dr Jason Huang
Address 122986 0
Royal Brisbane & Women's Hospital
Department of Gastroenterology & Hepatology
Level 7 Ned Hanon Building,
Butterfield Street, Herston, 4029
Queensland
Country 122986 0
Australia
Phone 122986 0
+61 7 364670335
Fax 122986 0
Email 122986 0
[email protected]
Contact person for public queries
Name 122987 0
Kimberley Ryan
Address 122987 0
Royal Brisbane & Women's Hospital
Department of Gastroenterology & Hepatology
Level 7 Ned Hanon Building,
Butterfield Street, Herston, 4029
Queensland
Country 122987 0
Australia
Phone 122987 0
+61 7 36468111
Fax 122987 0
Email 122987 0
[email protected]
Contact person for scientific queries
Name 122988 0
Jason Huang
Address 122988 0
Royal Brisbane & Women's Hospital
Department of Gastroenterology & Hepatology
Level 7 Ned Hanon Building,
Butterfield Street, Herston, 4029
Queensland
Country 122988 0
Australia
Phone 122988 0
+61 7 36470335
Fax 122988 0
Email 122988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No data sharing is permitted due to Ethical reasons


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.