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, 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, Dutch Pancreatitis Study Group
Přispěvatelé: Gastroenterology and hepatology, AGEM - Digestive immunity, Gastroenterology and Hepatology, AGEM - Re-generation and cancer of the digestive system, Surgery, Graduate School, Gastroenterology & Hepatology
Jazyk: angličtina
Rok vydání: 2018
Předmět:
NSAIDs
medicine.medical_treatment
Medicine (miscellaneous)
Hydration
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Clinical endpoint
Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14]
Medicine
Multicenter Studies as Topic
Pharmacology (medical)
Post-ERCP pancreatitis
Saline
Randomized Controlled Trials as Topic
Aged
80 and over
Cholangiopancreatography
Endoscopic Retrograde
lcsh:R5-920
Incidence (epidemiology)
Data Collection
Anti-Inflammatory Agents
Non-Steroidal
Middle Aged
3. Good health
Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10]
030220 oncology & carcinogenesis
Anesthesia
030211 gastroenterology & hepatology
lcsh:Medicine (General)
Adult
Ringer's Lactate
Combination therapy
Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0]
digestive system
Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18]
03 medical and health sciences
ERCP
Administration
Rectal
Humans
Aged
business.industry
Prevention
medicine.disease
digestive system diseases
Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11]
Pancreatitis
Sample Size
Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5]
business
Complication
Post ercp pancreatitis
Zdroj: Trials
Trials, 19
Trials, Vol 19, Iss 1, Pp 1-9 (2018)
Trials, 19(1). BioMed Central
Dutch Pancreatitis Study Group 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, vol. 19, no. 1, 207 . https://doi.org/10.1186/s13063-018-2583-x
Trials, 19(1):207. BioMed Central
Trials, 19:207. BioMed Central Ltd.
ISSN: 2015-0008
1745-6215
DOI: 10.1186/s13063-018-2583-x
Popis: 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.
Databáze: OpenAIRE
Externí odkaz: