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Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal

Xavier J N M Smeets1, David W da Costa2, Paul Fockens3

  • 1Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands. xavier.smeets@radboudumc.nl.

Trials
|April 3, 2018
PubMed

Insights

Vigorous hydration combined with rectal NSAIDs may reduce post-ERCP pancreatitis incidence in high-risk patients. This study investigates the effectiveness of this combination therapy for preventing post-ERCP pancreatitis.

Area of Science:

  • Gastroenterology
  • Clinical Trials
  • Medical Interventions

Background:

  • Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a common and potentially severe complication.
  • Current evidence on periprocedural hydration for PEP prevention has methodological limitations.
  • The added benefit and cost-effectiveness of hydration alongside prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) for PEP prevention remain uninvestigated.

Purpose of the Study:

  • To evaluate if combination therapy of rectal NSAIDs and periprocedural hydration significantly reduces PEP incidence compared to rectal NSAIDs alone.
  • To assess the impact on PEP severity, hydration-related complications, and cost-effectiveness.

Main Methods:

  • The FLUYT trial is a multicenter, open-label, superiority randomized controlled trial involving 826 moderate- to high-risk patients.
  • Patients received prophylactic rectal NSAIDs and were randomized to either a control group (limited hydration) or an intervention group (lactated Ringer's solution with a specific hydration schedule).
  • Primary endpoint: PEP incidence. Secondary endpoints: PEP severity, hydration complications, cost-effectiveness.

Main Results:

  • This section is not available in the provided abstract.

Conclusions:

  • The FLUYT trial is designed with a robust hydration protocol, fluid selection, and sample size to effectively detect differences in PEP incidence.
  • The trial aims to provide crucial evidence on the efficacy of combined hydration and NSAID therapy for PEP prevention.
Abstract

Keywords:
ERCPHydrationNSAIDsPost-ERCP pancreatitisPrevention

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