Journal Article

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

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

2018

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Administration, Rectal / Adult / Aged / Aged, 80 and over / Anti-Inflammatory Agents, Non-Steroidal - administration & dosage / Anti-Inflammatory Agents, Non-Steroidal - adverse effects / Biomedicine / Body mass index / Cholangiopancreatography, Endoscopic Retrograde - adverse effects / Clinical trials / Complications and side effects / Data Collection / Diagnosis / Dosage and administration / Drinking (Physiology) / Drug therapy / Edema / Endoscopic retrograde cholangiopancreatography / Endoscopy / Equivalence Trials as Topic / ERCP / Health aspects / Health Sciences / Heart failure / Humans / Hydration / Intervention / Medicine / Medicine & Public Health / Middle Aged / Multicenter Studies as Topic / Nonsteroidal anti-inflammatory drugs / NSAIDs / Pancreatitis / Pancreatitis - prevention & control / Post-ERCP pancreatitis / Prevention / Randomized Controlled Trials as Topic / Ringer's Lactate - administration & dosage / Ringer's Lactate - adverse effects / Sample Size / Statistics for Life Sciences / Study Protocol