Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement (REPEAT-PPG)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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 After the first set, the system will be flushed, the needle withdrawn from the liver, the system recalibrated, and the portal and hepatic veins punctured again for fresh triplicate readings.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 The needle is flushed and withdrawn into the liver parenchyma to a position immediately beneath the capsule, without crossing it, so that no further capsular puncture is performed.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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Michael Praktiknjo, MD PhD
- Telefonní číslo: +49 251 83 44826
- E-mail: michael.praktiknjo@ukmuenster.de
Studijní záloha kontaktů
- Jméno: Dominik van de Loo, MD
- Telefonní číslo: +49 251 83 44476
- E-mail: dominikjulian.vandeloo@ukmuenster.de
Studijní místa
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Leuven, Belgie
- UZ Leuven
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Kontakt:
- Wim Laleman, MD PhD
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Lazio
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Rome, Lazio, Itálie, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Kontakt:
- Francesco Santoapolo, MD
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Quebec
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Montreal, Quebec, Kanada
- McGill University Health Centre
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Kontakt:
- Amine Benmassaoud, MD
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Montreal, Quebec, Kanada
- Centre hospitalier de l'Université de Montréal (CHUM)
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Kontakt:
- Philippe Willems, MD
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Německo, 48149
- University Hospital Muenster
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Kontakt:
- Michael Praktiknjo, MD PhD
- Telefonní číslo: +49 251 83 44826
- E-mail: michael.praktiknjo@ukmuenster.de
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Same expert operator
Both complete measurement sets are performed by the same expert operator. |
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. |
|
Two expert operators
The two complete measurement sets are performed by two different expert operators, with order randomised. |
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. |
|
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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Within-session repeatability coefficient of EUS-PPG measured by the same expert operator
Časové okno: During the index EUS-PPG procedure
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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. |
During the index EUS-PPG procedure
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Inter-operator reproducibility coefficient of EUS-PPG
Časové okno: During the index EUS-PPG procedure
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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. |
During the index EUS-PPG procedure
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Variance components of repeated EUS-PPG measurements
Časové okno: During the index EUS-PPG procedure
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A mixed-effects model using all individual readings will estimate patient-, procedure-list-, operator-, measurement-set-, and reading-level variance components. |
During the index EUS-PPG procedure
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Intraclass correlation coefficient for paired EUS-PPG measurements
Časové okno: During the index EUS-PPG procedure
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Two-way absolute-agreement intraclass correlation coefficients will be reported overall and by operator configuration with 95% confidence intervals. |
During the index EUS-PPG procedure
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Bland-Altman agreement of paired EUS-PPG measurements
Časové okno: During the index EUS-PPG procedure
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Bias and 95% limits of agreement will be calculated overall and separately by operator pairing. |
During the index EUS-PPG procedure
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Discordant classification at portal pressure gradient thresholds of 10 mmHg and 12 mmHg
Časové okno: During the index EUS-PPG procedure
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The proportion of participants whose classification crosses the 10-mmHg or 12-mmHg threshold between the two measurement sets will be reported. |
During the index EUS-PPG procedure
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Procedure-associated adverse events
Časové okno: From the index procedure through 30 days
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Adverse events will include bleeding, pain, hemoglobin decrease, sedation-related events, unplanned admission or prolongation of stay, transfusion, and unplanned intervention. |
From the index procedure through 30 days
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Walter 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.
- Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Groszmann 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.
- 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.
- Reverter 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.
- de 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.
- Kottner 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.
- 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.
- Keiding 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.
- Tandon 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.
- Bai 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- REPEAT-PPG
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