Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis (PuSH)
2026年8月18日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
1300
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nicholas Burgess
- 電話番号：+61288905555
- メール：nicholas.burgess@health.nsw.gov.au
研究連絡先のバックアップ
- 名前：Brian Lam
- メール：briannicholas.lam@mail.utoronto.ca
研究場所
-
-
New South Wales
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Westmead、New South Wales、オーストラリア、2145
- 募集
- Westmead Hospital
-
コンタクト：
- Brian Lam
- メール：briannicholas.lam@mail.utoronto.ca
-
コンタクト：
- Nicholas Burgess
- 電話番号：+61288905555
- メール：nicholas.burgess@health.nsw.go.vau
-
主任研究者：
- Nicholas Burgess
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
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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アクティブコンパレータ：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).
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of post-ERCP pancreatitis (PEP)
時間枠：Within 72 hours after ERCP (onset within 24 hours)
|
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.
|
Within 72 hours after ERCP (onset within 24 hours)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PEP not fulfilling full Cotton criteria
時間枠：Within 72 hours after ERCP (onset within 24 hours)
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
Within 30 days after ERCP
|
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Cost effectiveness
時間枠：Within 30 days after ERCP
|
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
時間枠：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.
|
Within 30 days of ERCP
|
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Hospitalization for PEP Length of Stay
時間枠：Within 30 days of ERCP
|
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.
|
Within 30 days of ERCP
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Nicholas Burgess、Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月1日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2029年6月1日
試験登録日
最初に提出
2026年8月5日
QC基準を満たした最初の提出物
2026年8月18日
最初の投稿 (実際)
2026年8月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月20日
QC基準を満たした最後の更新が送信されました
2026年8月18日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2019/ETH13255
個々の参加者データ (IPD) の計画
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いいえ
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