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

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. Impo...

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Detalles Bibliográficos
Autores principales: Smeets, Xavier J. N. M., da Costa, David W., Fockens, Paul, Mulder, Chris J. J., Timmer, Robin, Kievit, Wietske, Zegers, Marieke, Bruno, Marco J., Besselink, Marc G. H., Vleggaar, Frank P., van der Hulst, Rene W. M., Poen, Alexander C., Heine, Gerbrand D. N., Venneman, Niels G., Kolkman, Jeroen J., Baak, Lubbertus C., Römkens, Tessa E. H., van Dijk, Sven M., Hallensleben, Nora D. L., van de Vrie, Wim, Seerden, Tom C. J., Tan, Adriaan C. I. T. L., Voorburg, Annet M. C. J., Poley, Jan-Werner, Witteman, Ben J., Bhalla, Abha, Hadithi, Muhammed, Thijs, Willem J., Schwartz, Matthijs P., Vrolijk, Jan Maarten, Verdonk, Robert C., van Delft, Foke, Keulemans, Yolande, van Goor, Harry, Drenth, Joost P. H., van Geenen, Erwin J. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Study Protocol
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5879873/
https://www.ncbi.nlm.nih.gov/pubmed/29606135
http://dx.doi.org/10.1186/s13063-018-2583-x
Descripción
Sumario: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. TRIAL REGISTRATION: EudraCT: 2015-000829-37. Registered on 18 February 2015. ISRCTN: 13659155. Registered on 18 May 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2583-x) contains supplementary material, which is available to authorized users.

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