Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis (PuSH)
18. srpna 2026 aktualizováno: Nicholas Burgess, Westmead Hospital
Preventing Post ERCP Pancreatitis by Short Stay Aggressive Hydration (PuSH) -a Prospective Randomized Trial.
Post-ERCP pancreatitis (PEP) is the most common serious adverse event after endoscopic retrograde cholangiopancreatography (ERCP), occurring in roughly 7-15% of patients. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and peri-procedural aggressive intravenous hydration each reduce PEP, but published hydration regimens are delivered over 8-24 hours and require an overnight hospital stay, which is impractical where ERCP is increasingly performed as a same-day procedure.
This multicentre, prospective, randomised controlled trial tests whether a short (under 4 hours) aggressive hydration regimen with Lactated Ringer's solution, combined with rectal indomethacin, is superior to standard care (rectal indomethacin plus low-volume hydration) for preventing PEP, while supporting same-day discharge. Adults undergoing ERCP are randomised 1:1. The primary outcome is the incidence of PEP defined by consensus (Cotton) criteria. A total of 1300 participants (650 per arm) will be enrolled.
Přehled studie
Postavení
Nábor
Podmínky
Detailní popis
Design: multicentre, parallel-group, superiority RCT with 1:1 allocation, conducted in high-volume tertiary academic endoscopy units.
Interventions: All participants receive 100 mg indomethacin per rectum within 30 minutes before or after ERCP. Participants randomised to aggressive hydration receive a peri-procedural bolus of Lactated Ringer's 20 mL/kg over ~1 hour, then 3 mL/kg/hour for 3 hours (post-procedure infusion capped at 1000 mL). Participants randomised to standard care receive low-volume Lactated Ringer's at the discretion of the endoscopist/anaesthetist (up to 1.5 mL/kg/hour, max 500 mL over 3 hours). For BMI > 40 kg/m2, infusion rates are capped assuming a BMI of 40. Pancreatic duct stenting is permitted in both arms at the proceduralist's discretion per guidelines. Aggressive hydration is discontinued if signs of fluid overload develop.
Follow-up: pre-discharge assessment (fluid-overload exam, pain), a 24-hour telephone follow-up (bloods if symptomatic), and a 30-day telephone follow-up for delayed events and hospitalisation.
Analysis: primary analysis by intention-to-treat; per-protocol analysis also performed. Statistical analysis is conducted blinded to allocation.
Typ studie
Intervenční
Zápis (Odhadovaný)
1300
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Nicholas Burgess
- Telefonní číslo: +61288905555
- E-mail: nicholas.burgess@health.nsw.gov.au
Studijní záloha kontaktů
- Jméno: Brian Lam
- E-mail: briannicholas.lam@mail.utoronto.ca
Studijní místa
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New South Wales
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Westmead, New South Wales, Austrálie, 2145
- Nábor
- Westmead Hospital
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Kontakt:
- Brian Lam
- E-mail: briannicholas.lam@mail.utoronto.ca
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Kontakt:
- Nicholas Burgess
- Telefonní číslo: +61288905555
- E-mail: nicholas.burgess@health.nsw.go.vau
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Vrchní vyšetřovatel:
- Nicholas Burgess
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Age over 18 years
- Undergoing ERCP
- Able to provide informed consent
Exclusion Criteria:
- Unable to give consent
- Clinical signs/symptoms of congestive cardiac failure (pitting oedema, NYHA class ≥ 2, or oxygen saturation ≤ 90%)
- Respiratory failure (pre-procedure SpO2 < 90% on room air, or requirement for non-invasive/mechanical ventilation)
- Contraindication to rectal NSAIDs (allergy; active gastrointestinal bleeding)
- Estimated GFR (MDRD) ≤ 30 mL/min
- Altered biliary or duodenal anatomy (e.g. prior biliary/pancreatic surgery, Roux-en-Y reconstruction)
- Known hypo- or hypernatraemia (serum sodium < 130 or > 150 mmol/L)
- Pregnancy
- Severe liver disease (cirrhosis with ascites)
- Previous sphincterotomy (unless undergoing pancreatic duct intervention)
- Acute pancreatitis
- Chronic pancreatitis (unless undergoing a pancreatic duct intervention)
- Sphincter of Oddi dysfunction
- Pancreatic mass causing biliary obstruction
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Aggressive Hydration
Rectal indomethacin 100 mg plus short-stay aggressive hydration: Lactated Ringer's bolus 20 mL/kg over ~1 hour, then 3 mL/kg/hour for 3 hours (post-procedure infusion capped at 1000 mL).
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Lactated Ringer's bolus 20 mL/kg over ~1 hour then 3 mL/kg/hour x 3 hours (cap 1000 mL post-procedure); rate capped at BMI 40 if BMI > 40.
Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.
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Aktivní komparátor: Standard Care
Rectal indomethacin 100 mg plus standard low-volume hydration at proceduralist/anaesthetist discretion (Lactated Ringer's up to 1.5 mL/kg/hour, max 500 mL over 3 hours).
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Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.
Low-volume Lactated Ringer's at operator discretion, up to 1.5 mL/kg/hour, max 500 mL over 3 hours.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of post-ERCP pancreatitis (PEP)
Časové okno: Within 72 hours after ERCP (onset within 24 hours)
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PEP defined by consensus (Cotton) criteria, requiring ALL of: new or worsened upper abdominal pain; serum amylase or lipase at least 3x the upper limit of normal; pain and enzyme elevation persisting for at least 24 hours; and hospitalisation (or prolongation) of at least 2 days attributable to pancreatitis.
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Within 72 hours after ERCP (onset within 24 hours)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PEP not fulfilling full Cotton criteria
Časové okno: Within 72 hours after ERCP (onset within 24 hours)
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Post-ERCP pancreatitis not meeting full Cotton criteria.
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Within 72 hours after ERCP (onset within 24 hours)
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Delayed PEP
Časové okno: 24 hours to 30 days after ERCP
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Post-ERCP pancreatitis (by Cotton criteria) with onset more than 24 hours after ERCP, identified after initial discharge.
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24 hours to 30 days after ERCP
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Severity of PEP
Časové okno: Within 30 days after ERCP
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Severity graded by Cotton criteria and the Revised Atlanta Classification
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Within 30 days after ERCP
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ERCP associated adverse events
Časové okno: Within 30 days after ERCP
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ERCP-associated adverse events graded by consensus (Cotton) criteria as mild, moderate, or severe: bleeding, perforation, and infection (cholangitis).
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Within 30 days after ERCP
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Signs of fluid overload
Časové okno: Peri-procedural to 24 hours after ERCP
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Pulmonary oedema, peripheral (pitting) oedema, or exacerbation of congestive cardiac failure.
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Peri-procedural to 24 hours after ERCP
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Hospitalization for any reason within 30 days
Časové okno: Within 30 days after ERCP
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Proportion of participants hospitalised (including unplanned admission or readmission) for any reason within 30 days of ERCP.
Ascertained from medical records and the 30-day follow-up call.
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Within 30 days after ERCP
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Cost effectiveness
Časové okno: Within 30 days after ERCP
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Cost-effectiveness of short-stay aggressive hydration versus standard care, comparing total cost of healthcare resource use (intravenous fluids and consumables, procedure/recovery time, length of stay, and PEP-related admissions or readmissions) in relation to PEP cases avoided.
Reported as incremental cost effectiveness ratio (ICER) for post-ERCP pancreatitis cases avoided.
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Within 30 days after ERCP
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Hospitalization Length of Stay
Časové okno: Within 30 days of ERCP
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In participants hospitalised (including unplanned admission or readmission) for any reason within 30 days of ERCP, the length of hospital stay measured in days.
Ascertained from medical records and the 30-day follow-up call.
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Within 30 days of ERCP
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Hospitalization for PEP Length of Stay
Časové okno: Within 30 days of ERCP
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In participants hospitalised (including unplanned admission or readmission) for PEP within 30 days of ERCP, the length of hospital stay measured in days.
Ascertained from medical records and the 30-day follow-up call.
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Within 30 days of ERCP
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Nicholas Burgess, Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
- Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.
- Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2014 Feb;12(2):303-7.e1. doi: 10.1016/j.cgh.2013.07.026. Epub 2013 Aug 3.
- Sperna Weiland CJ, Smeets XJNM, Kievit W, Verdonk RC, Poen AC, Bhalla A, Venneman NG, Witteman BJM, da Costa DW, van Eijck BC, Schwartz MP, Romkens TEH, Vrolijk JM, Hadithi M, Voorburg AMCJ, Baak LC, Thijs WJ, van Wanrooij RL, Tan ACITL, Seerden TCJ, Keulemans YCA, de Wijkerslooth TR, van de Vrie W, van der Schaar P, van Dijk SM, Hallensleben NDL, Sperna Weiland RL, Timmerhuis HC, Umans DS, van Hooft JE, van Goor H, van Santvoort HC, Besselink MG, Bruno MJ, Fockens P, Drenth JPH, van Geenen EJM; Dutch Pancreatitis Study Group. Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2021 May;6(5):350-358. doi: 10.1016/S2468-1253(21)00057-1. Epub 2021 Mar 19.
- Tenner S, Vege SS, Sheth SG, Sauer B, Yang A, Conwell DL, Yadlapati RH, Gardner TB. American College of Gastroenterology Guidelines: Management of Acute Pancreatitis. Am J Gastroenterol. 2024 Mar 1;119(3):419-437. doi: 10.14309/ajg.0000000000002645. Epub 2023 Nov 7.
- Hattori A, Yamada R, Murabayashi T, Sugimoto S, Imai H, Nojiri K, Kuroda N, Tano S, Tanaka H, Matsusaki S, Nishikawa K, Naota H, Moritani I, Kurata K, Fukui T, Tanaka K, Nakagawa H. The safety and efficacy of Ringer's solution loading with rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: The RESOLUTION-PEP study. DEN Open. 2023 Apr 26;3(1):e236. doi: 10.1002/deo2.236. eCollection 2023 Apr.
- Wang RC, Jiang ZK, Xie YK, Chen JS. Aggressive hydration compared to standard hydration with lactated ringer's solution for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis. Surg Endosc. 2021 Mar;35(3):1126-1137. doi: 10.1007/s00464-020-07477-9. Epub 2020 Mar 5.
- Wu M, Jiang S, Lu X, Zhong Y, Song Y, Fan Z, Kang X. Aggressive hydration with lactated ringer solution in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis. Medicine (Baltimore). 2021 Apr 23;100(16):e25598. doi: 10.1097/MD.0000000000025598.
- Patel R, Bertran-Rodriguez C, Kumar A, Brady P, Gomez-Esquivel R, Changela K, Niknam N, Taunk P. Efficacy of aggressive hydration with normal saline versus lactated Ringer's solution for the prevention of post-ERCP pancreatitis in high-risk patients: a randomized controlled trial. Endosc Int Open. 2022 Jul 15;10(7):E933-E939. doi: 10.1055/a-1834-6568. eCollection 2022 Jul.
- Cho E, Kim SH, Park CH, Yoon JH, Lee SO, Kim TH, Chon HK. Tailored Hydration With Lactated Ringer's Solution for Postendoscopic Retrograde Cholangiopancreatography Pancreatitis Prevention: A Randomized Controlled Trial. Am J Gastroenterol. 2024 Dec 1;119(12):2426-2435. doi: 10.14309/ajg.0000000000002903. Epub 2024 Jun 24.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. června 2026
Primární dokončení (Odhadovaný)
1. prosince 2028
Dokončení studie (Odhadovaný)
1. června 2029
Termíny zápisu do studia
První předloženo
5. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
18. srpna 2026
První zveřejněno (Aktuální)
20. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
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Další identifikační čísla studie
- 2019/ETH13255
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