Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis (PuSH)
18 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
1300
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Nicholas Burgess
- Numéro de téléphone: +61288905555
- E-mail: nicholas.burgess@health.nsw.gov.au
Sauvegarde des contacts de l'étude
- Nom: Brian Lam
- E-mail: briannicholas.lam@mail.utoronto.ca
Lieux d'étude
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New South Wales
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Westmead, New South Wales, Australie, 2145
- Recrutement
- Westmead Hospital
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Contact:
- Brian Lam
- E-mail: briannicholas.lam@mail.utoronto.ca
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Contact:
- Nicholas Burgess
- Numéro de téléphone: +61288905555
- E-mail: nicholas.burgess@health.nsw.go.vau
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Chercheur principal:
- Nicholas Burgess
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of post-ERCP pancreatitis (PEP)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PEP not fulfilling full Cotton criteria
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Nicholas Burgess, Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2026
Achèvement primaire (Estimé)
1 décembre 2028
Achèvement de l'étude (Estimé)
1 juin 2029
Dates d'inscription aux études
Première soumission
5 août 2026
Première soumission répondant aux critères de contrôle qualité
18 août 2026
Première publication (Réel)
20 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2019/ETH13255
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