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.

Autor: Smeets XJNM; Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands. xavier.smeets@radboudumc.nl., da Costa DW; Department of Radiology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands., Fockens P; Department of Gastroenterology and Hepatology, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands., Mulder CJJ; Department of Gastroenterology and Hepatology, VU University Medical Centre Amsterdam, PO Box 7057, 1007 MB, Amsterdam, The Netherlands., Timmer R; Department of Gastroenterology and Hepatology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands., Kievit W; Department of Health Evidence, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands., Zegers M; Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands., Bruno MJ; Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands., Besselink MGH; Department of Surgery, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands., Vleggaar FP; Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, PO 85500, 3508 GA, Utrecht, The Netherlands., van der Hulst RWM; Department of Gastroenterology and Hepatology, Spaarne Gasthuis, PO 417, 2000 AK, Haarlem, The Netherlands., Poen AC; Department of Gastroenterology and Hepatology, Isala Klinieken, PO 10400, 8000 GK, Zwolle, The Netherlands., Heine GDN; Department of Gastroenterology and Hepatology, Noord-West Hospital, PO 501, 1800 AM, Alkmaar, The Netherlands., Venneman NG; Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, PO 50000, 7500 KA, Enschede, The Netherlands., Kolkman JJ; Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, PO 50000, 7500 KA, Enschede, The Netherlands., Baak LC; Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Postbus 95500, 1090 HM, Amsterdam, The Netherlands., Römkens TEH; Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, PO 90153, 5200 ME, s'Hertogenbosch, The Netherlands., van Dijk SM; Department of Surgery, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands., Hallensleben NDL; Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands., van de Vrie W; Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, PO 444, 3300 AK, Dordrecht, The Netherlands., Seerden TCJ; Department of Gastroenterology and Hepatology, Amphia Hospital, PO 90158, 4800 RK, Breda, The Netherlands., Tan ACITL; Department of Gastroenterology and Hepatology, Canisius-Wilhelmina Hospital, PO 9015, 6500 GS, Nijmegen, The Netherlands., Voorburg AMCJ; Department of Gastroenterology and Hepatology, Diakonessenhuis, PO 80250, 3508 TG, Utrecht, The Netherlands., Poley JW; Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands., Witteman BJ; Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, PO 9025, 6710 HN, Ede, The Netherlands., Bhalla A; Department of Gastroenterology and Hepatology, HAGA Hospital, PO 40551, 2504 LN, The Hague, The Netherlands., Hadithi M; Department of Gastroenterology and Hepatology, Maasstad Hospital, PO 9100, 3007 AC, Rotterdam, The Netherlands., Thijs WJ; Department of Gastroenterology and Hepatology, Martini Hospital, PO 30033, 9700 RM, Groningen, The Netherlands., Schwartz MP; Department of Gastroenterology and Hepatology, Meander Medical Centre, PO 1502, 3800 BM, Amersfoort, The Netherlands., Vrolijk JM; Department of Gastroenterology and Hepatology, Rijnstate Hospital, PO 9555, 6800 TA, Arnhem, The Netherlands., Verdonk RC; Department of Gastroenterology and Hepatology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands., van Delft F; Department of Gastroenterology and Hepatology, VU University Medical Centre Amsterdam, PO Box 7057, 1007 MB, Amsterdam, The Netherlands., Keulemans Y; Department of Gastroenterology and Hepatology, Zuyderland, PO 5500, 6130 MB, Sittard-Geleen, The Netherlands., van Goor H; Department of Surgery, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands., Drenth JPH; Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands., van Geenen EJM; Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands.
Jazyk: angličtina
Zdroj: Trials [Trials] 2018 Apr 02; Vol. 19 (1), pp. 207. Date of Electronic Publication: 2018 Apr 02.
DOI: 10.1186/s13063-018-2583-x
Abstrakt: 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.
Databáze: MEDLINE
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