Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis

NCT07776561 | Recruiting DMC

• 1 other identifier: 2019/ETH13255
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-ERCP Pancreatitis; Pancreatitis

Keywords

ERCP; Post-ERCP pancreatitis; Aggressive hydration; Lactated Ringer's solution; Rectal indomethacin; Fluid resuscitation; Same-day discharge

Outcome Measures

Primary Outcomes (1)

• Incidence of post-ERCP pancreatitis (PEP)

  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)

Secondary Outcomes (9)

• PEP not fulfilling full Cotton criteria

  Within 72 hours after ERCP (onset within 24 hours)

• Delayed PEP

  24 hours to 30 days after ERCP

• Severity of PEP

  Within 30 days after ERCP

• ERCP associated adverse events

  Within 30 days after ERCP

• Signs of fluid overload

  Peri-procedural to 24 hours after ERCP

Study Arms (2)

Aggressive Hydration

EXPERIMENTAL

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).

Other: Short-Stay Aggressive Hydration; Drug: Rectal Indomethacin

Standard Care

ACTIVE COMPARATOR

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).

Other: Standard Peri-procedural Hydration; Drug: Rectal Indomethacin

Interventions

Short-Stay Aggressive Hydration OTHER

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.

Aggressive Hydration

Standard Peri-procedural Hydration OTHER

Low-volume Lactated Ringer's at operator discretion, up to 1.5 mL/kg/hour, max 500 mL over 3 hours.

Standard Care

Rectal Indomethacin DRUG

Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.

Aggressive Hydration; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Undergoing ERCP
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Westmead Hospital: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Related Publications (12)

• 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.

  PMID: 23100216 BACKGROUND

• 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.

  PMID: 2070995 BACKGROUND

• 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.

  PMID: 38857482 BACKGROUND

• 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.

  PMID: 25088919 BACKGROUND

• 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.

  PMID: 31863440 BACKGROUND

• 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.

  PMID: 37125072 BACKGROUND

• 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.

  PMID: 32140860 BACKGROUND

• 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.

  PMID: 33879722 BACKGROUND

• 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.

  PMID: 35845031 BACKGROUND

• 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.

  PMID: 23920031 BACKGROUND

• 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.

  PMID: 38912692 BACKGROUND

• 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.

  PMID: 33740415 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Nicholas Burgess

  Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Burgess

CONTACT

+61288905555; nicholas.burgess@health.nsw.gov.au

Brian Lam

CONTACT

briannicholas.lam@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 20, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)