Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial

Xavier J N M Smeets, David W da Costa, Paul Fockens, Chris J J Mulder, Robin Timmer, Wietske Kievit, Marieke Zegers, Marco J Bruno, Marc G H Besselink, Frank P Vleggaar, Rene W M van der Hulst, Alexander C Poen, Gerbrand D N Heine, Niels G Venneman, Jeroen J Kolkman, Lubbertus C Baak, Tessa E H Römkens, Sven M van Dijk, Nora D L Hallensleben, Wim van de VrieTom C J Seerden, Adriaan C I T L Tan, Annet M C J Voorburg, Jan-Werner Poley, Ben J Witteman, Abha Bhalla, Muhammed Hadithi, Willem J Thijs, Matthijs P Schwartz, Jan Maarten Vrolijk, Robert C Verdonk, Foke van Delft, Yolande Keulemans, Harry van Goor, Joost P H Drenth, Erwin J M van Geenen,

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. Methods: The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. Discussion: The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs.

Original languageEnglish
Article number207
JournalTrials
Volume19
Issue number1
DOIs
Publication statusPublished - 2 Apr 2018

Keywords

  • ERCP
  • Hydration
  • NSAIDs
  • Post-ERCP pancreatitis
  • Prevention

Fingerprint

Dive into the research topics of 'Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial'. Together they form a unique fingerprint.

Cite this