Portal HypertensionREPEAT-PPGNCT07877298
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
An observational study of Portal Hypertension and Chronic Liver Disease, run by University Hospital Muenster at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension, Chronic Liver Disease, Liver Cirrhosis
- What is being tested?
- Repeated EUS-Guided Portal Pressure Gradient Measurement
- How many people
- 150 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Jan 2027to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Canada2 sites
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
Philippe Willems, MD
McGill University Health Centre
Montreal, Quebec
Amine Benmassaoud, MD
Germany1 site
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
Michael Praktiknjo, MD PhD, +49 251 83 44826, michael.praktiknjo@ukmuenster.de
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
Francesco Santoapolo, MD
About this study
Official title: Within-Session Repeatability and Inter-Operator Reproducibility of EUS-Guided Portal Pressure Gradient Measurement: A Prospective Multicentre Study
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.
Read the detailed description
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 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. Two techniques of withdrawal are allowed. One technique includes transcapsular re-puncture. The needle is flushed and fully retracted from the liver. The other technique includes subcapsular retraction. The needle is flushed and withdrawn into the liver parenchyma to a position immediately beneath the capsule, without crossing it, so that no further capsular puncture is performed. 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.
- Conditions
- Portal Hypertension, Chronic Liver Disease, Liver Cirrhosis
- Being tested
- Repeated EUS-Guided Portal Pressure Gradient Measurement
- Keywords
- EUS-PPG, Endoscopic ultrasound, Portal pressure gradient, Portal hypertension, Repeatability, Reproducibility, Bland-Altman analysis, Intraclass correlation coefficient
- Medical subject headings
- Hypertension, Portal, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated EUS-Guided Portal Pressure Gradient MeasurementDiagnostic test
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 withdrawn with one of the allowed techniques, 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.
| Study group | Role | What they receive |
|---|---|---|
| Same expert operator | Both complete measurement sets are performed by the same expert operator. Receives: Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient Measurement | |
| Two expert operators | The two complete measurement sets are performed by two different expert operators, with order randomised. Receives: Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient Measurement | |
| Expert and trainee operators | One complete measurement set is performed by an expert and the other by a trainee under direct supervision, with order randomised. Receives: Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the index EUS-PPG procedure
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the index procedure through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Michael Praktiknjo, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877298
- Sponsor's protocol ID
- REPEAT-PPG
- Acronym
- REPEAT-PPG
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
International Organization for Standardization. ISO 5725-1:1994. Accuracy (trueness and precision) of measurement methods and results. Part 1: General principles and definitions. Geneva: ISO; 1994.
Bonett DG. Sample size requirements for estimating intraclass correlations with desired precision. Stat Med. 2002 May 15;21(9):1331-5. doi: 10.1002/sim.1108.
PubMed 12111881Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e.
PubMed 9463853Kottner J, Audige L, Brorson S, Donner A, Gajewski BJ, Hrobjartsson A, Roberts C, Shoukri M, Streiner DL. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. J Clin Epidemiol. 2011 Jan;64(1):96-106. doi: 10.1016/j.jclinepi.2010.03.002. Epub 2010 Jun 17.
PubMed 21130355Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
PubMed 35120736Keiding S, Vilstrup H. Intrahepatic heterogeneity of hepatic venous pressure gradient in human cirrhosis. Scand J Gastroenterol. 2002 Aug;37(8):960-4. doi: 10.1080/003655202760230946.
PubMed 12229973Reverter E, Blasi A, Abraldes JG, Martinez-Palli G, Seijo S, Turon F, Berzigotti A, Balust J, Bosch J, Garcia-Pagan JC. Impact of deep sedation on the accuracy of hepatic and portal venous pressure measurements in patients with cirrhosis. Liver Int. 2014 Jan;34(1):16-25. doi: 10.1111/liv.12229. Epub 2013 Jun 13.
PubMed 23763484Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology. 2004 Feb;39(2):280-2. doi: 10.1002/hep.20062. No abstract available.
PubMed 14767976Tandon P, Ripoll C, Assis D, Wongcharatrawee S, Groszmann RJ, Garcia-Tsao G. The interpretation of hepatic venous pressure gradient tracings - excellent interobserver agreement unrelated to experience. Liver Int. 2016 Aug;36(8):1160-6. doi: 10.1111/liv.13065. Epub 2016 Feb 8.
PubMed 26763558Bai W, Al-Karaghouli M, Stach J, Sung S, Matheson GJ, Abraldes JG. Test-Retest Reliability and Consistency of HVPG and Impact on Trial Design: A Study in 289 Patients from 20 Randomized Controlled Trials. Hepatology. 2021 Dec;74(6):3301-3315. doi: 10.1002/hep.32033. Epub 2021 Aug 15.
PubMed 34181770
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Within-Session Repeatability and Inter-Operator Reproducibility of EUS-Guided Portal Pressure Gradient Measurement: A Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT07877298
- Acronym / sponsor ID
- REPEAT-PPG / REPEAT-PPG
- Conditions
- Portal Hypertension, Chronic Liver Disease, Liver Cirrhosis
- Keywords
- EUS-PPG, Endoscopic ultrasound, Portal pressure gradient, Portal hypertension, Repeatability, Reproducibility, Bland-Altman analysis, Intraclass correlation coefficient
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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. Two techniques of withdrawal are allowed. One technique includes transcapsular re-puncture. The needle is flushed and fully retracted from the liver. The other technique includes subcapsular retraction. The needle is flushed and withdrawn into the liver parenchyma to a position immediately beneath the capsule, without crossing it, so that no further capsular puncture is performed. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Same expert operator | – | Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient MeasurementBoth complete measurement sets are performed by the same expert operator. |
| Two expert operators | – | Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient MeasurementThe two complete measurement sets are performed by two different expert operators, with order randomised. |
| Expert and trainee operators | – | Diagnostic Test: Repeated EUS-Guided Portal Pressure Gradient MeasurementOne complete measurement set is performed by an expert and the other by a trainee under direct supervision, with order randomised. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated EUS-Guided Portal Pressure Gradient MeasurementDuring 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 withdrawn with one of the allowed techniques, 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. | Diagnostic test | Expert and trainee operators, Same expert operator, Two expert operators |
Primary outcome
Within-session repeatability coefficient of EUS-PPG measured by the same expert operator
Time frame: During the index EUS-PPG procedure
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.
6 secondary outcomes
Inter-operator reproducibility coefficient of EUS-PPG
Time frame: During the index EUS-PPG procedure
Variance components of repeated EUS-PPG measurements
Time frame: During the index EUS-PPG procedure
Intraclass correlation coefficient for paired EUS-PPG measurements
Time frame: During the index EUS-PPG procedure
Bland-Altman agreement of paired EUS-PPG measurements
Time frame: During the index EUS-PPG procedure
Discordant classification at portal pressure gradient thresholds of 10 mmHg and 12 mmHg
Time frame: During the index EUS-PPG procedure
Procedure-associated adverse events
Time frame: From the index procedure through 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- BackgroundInternational Organization for Standardization. ISO 5725-1:1994. Accuracy (trueness and precision) of measurement methods and results. Part 1: General principles and definitions. Geneva: ISO; 1994.
- Background: PubMed 12111881Bonett DG. Sample size requirements for estimating intraclass correlations with desired precision. Stat Med. 2002 May 15;21(9):1331-5. doi: 10.1002/sim.1108.
- Background: PubMed 9463853Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e.
- Background: PubMed 21130355Kottner J, Audige L, Brorson S, Donner A, Gajewski BJ, Hrobjartsson A, Roberts C, Shoukri M, Streiner DL. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. J Clin Epidemiol. 2011 Jan;64(1):96-106. doi: 10.1016/j.jclinepi.2010.03.002. Epub 2010 Jun 17.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 35120736de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
- Background: PubMed 12229973Keiding S, Vilstrup H. Intrahepatic heterogeneity of hepatic venous pressure gradient in human cirrhosis. Scand J Gastroenterol. 2002 Aug;37(8):960-4. doi: 10.1080/003655202760230946.
- Background: PubMed 23763484Reverter E, Blasi A, Abraldes JG, Martinez-Palli G, Seijo S, Turon F, Berzigotti A, Balust J, Bosch J, Garcia-Pagan JC. Impact of deep sedation on the accuracy of hepatic and portal venous pressure measurements in patients with cirrhosis. Liver Int. 2014 Jan;34(1):16-25. doi: 10.1111/liv.12229. Epub 2013 Jun 13.
- Background: PubMed 14767976Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology. 2004 Feb;39(2):280-2. doi: 10.1002/hep.20062. No abstract available.
- Background: PubMed 26763558Tandon P, Ripoll C, Assis D, Wongcharatrawee S, Groszmann RJ, Garcia-Tsao G. The interpretation of hepatic venous pressure gradient tracings - excellent interobserver agreement unrelated to experience. Liver Int. 2016 Aug;36(8):1160-6. doi: 10.1111/liv.13065. Epub 2016 Feb 8.
- Background: PubMed 34181770Bai W, Al-Karaghouli M, Stach J, Sung S, Matheson GJ, Abraldes JG. Test-Retest Reliability and Consistency of HVPG and Impact on Trial Design: A Study in 289 Patients from 20 Randomized Controlled Trials. Hepatology. 2021 Dec;74(6):3301-3315. doi: 10.1002/hep.32033. Epub 2021 Aug 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Chronic Liver Disease, run by University Hospital Muenster at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Belgium, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Praktiknjo, MD PhD (+49 251 83 44826, michael.praktiknjo@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-session repeatability coefficient of EUS-PPG measured by the same expert operator (time frame: During the index EUS-PPG procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07877298, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.