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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.
Trials 2018; 19(1):207T

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.

TRIAL REGISTRATION

EudraCT: 2015-000829-37 . Registered on 18 February 2015.

ISRCTN

13659155 . Registered on 18 May 2015.

Authors+Show Affiliations

Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands. xavier.smeets@radboudumc.nl.Department of Radiology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands.Department of Gastroenterology and Hepatology, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands.Department of Gastroenterology and Hepatology, VU University Medical Centre Amsterdam, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.Department of Gastroenterology and Hepatology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands.Department of Health Evidence, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands.Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands.Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands.Department of Surgery, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands.Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, PO 85500, 3508 GA, Utrecht, The Netherlands.Department of Gastroenterology and Hepatology, Spaarne Gasthuis, PO 417, 2000 AK, Haarlem, The Netherlands.Department of Gastroenterology and Hepatology, Isala Klinieken, PO 10400, 8000 GK, Zwolle, The Netherlands.Department of Gastroenterology and Hepatology, Noord-West Hospital, PO 501, 1800 AM, Alkmaar, The Netherlands.Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, PO 50000, 7500 KA, Enschede, The Netherlands.Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, PO 50000, 7500 KA, Enschede, The Netherlands.Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Postbus 95500, 1090 HM, Amsterdam, The Netherlands.Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, PO 90153, 5200 ME, s'Hertogenbosch, The Netherlands.Department of Surgery, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands.Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands.Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, PO 444, 3300 AK, Dordrecht, The Netherlands.Department of Gastroenterology and Hepatology, Amphia Hospital, PO 90158, 4800 RK, Breda, The Netherlands.Department of Gastroenterology and Hepatology, Canisius-Wilhelmina Hospital, PO 9015, 6500 GS, Nijmegen, The Netherlands.Department of Gastroenterology and Hepatology, Diakonessenhuis, PO 80250, 3508 TG, Utrecht, The Netherlands.Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands.Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, PO 9025, 6710 HN, Ede, The Netherlands.Department of Gastroenterology and Hepatology, HAGA Hospital, PO 40551, 2504 LN, The Hague, The Netherlands.Department of Gastroenterology and Hepatology, Maasstad Hospital, PO 9100, 3007 AC, Rotterdam, The Netherlands.Department of Gastroenterology and Hepatology, Martini Hospital, PO 30033, 9700 RM, Groningen, The Netherlands.Department of Gastroenterology and Hepatology, Meander Medical Centre, PO 1502, 3800 BM, Amersfoort, The Netherlands.Department of Gastroenterology and Hepatology, Rijnstate Hospital, PO 9555, 6800 TA, Arnhem, The Netherlands.Department of Gastroenterology and Hepatology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands.Department of Gastroenterology and Hepatology, VU University Medical Centre Amsterdam, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.Department of Gastroenterology and Hepatology, Zuyderland, PO 5500, 6130 MB, Sittard-Geleen, The Netherlands.Department of Surgery, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands.Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands.Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

29606135

Citation

Smeets, Xavier J N M., et al. "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." Trials, vol. 19, no. 1, 2018, p. 207.
Smeets XJNM, da Costa DW, Fockens P, et al. 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. Trials. 2018;19(1):207.
Smeets, X. J. N. M., da Costa, D. W., Fockens, P., Mulder, C. J. J., Timmer, R., Kievit, W., ... van Geenen, E. J. M. (2018). 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. Trials, 19(1), p. 207. doi:10.1186/s13063-018-2583-x.
Smeets XJNM, et al. 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. Trials. 2018 Apr 2;19(1):207. PubMed PMID: 29606135.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Smeets,Xavier J N M, AU - da Costa,David W, AU - Fockens,Paul, AU - Mulder,Chris J J, AU - Timmer,Robin, AU - Kievit,Wietske, AU - Zegers,Marieke, AU - Bruno,Marco J, AU - Besselink,Marc G H, AU - Vleggaar,Frank P, AU - van der Hulst,Rene W M, AU - Poen,Alexander C, AU - Heine,Gerbrand D N, AU - Venneman,Niels G, AU - Kolkman,Jeroen J, AU - Baak,Lubbertus C, AU - Römkens,Tessa E H, AU - van Dijk,Sven M, AU - Hallensleben,Nora D L, AU - van de Vrie,Wim, AU - Seerden,Tom C J, AU - Tan,Adriaan C I T L, AU - Voorburg,Annet M C J, AU - Poley,Jan-Werner, AU - Witteman,Ben J, AU - Bhalla,Abha, AU - Hadithi,Muhammed, AU - Thijs,Willem J, AU - Schwartz,Matthijs P, AU - Vrolijk,Jan Maarten, AU - Verdonk,Robert C, AU - van Delft,Foke, AU - Keulemans,Yolande, AU - van Goor,Harry, AU - Drenth,Joost P H, AU - van Geenen,Erwin J M, AU - ,, Y1 - 2018/04/02/ PY - 2018/01/02/received PY - 2018/03/06/accepted PY - 2018/4/3/entrez PY - 2018/4/3/pubmed PY - 2019/3/23/medline KW - ERCP KW - Hydration KW - NSAIDs KW - Post-ERCP pancreatitis KW - Prevention SP - 207 EP - 207 JF - Trials JO - Trials VL - 19 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29606135/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2583-x DB - PRIME DP - Unbound Medicine ER -