Background
Methods
Study setting
Eligibility criteria
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Low risk of post-ERCP pancreatitis: (1) definite chronic pancreatitis according to MANNHEIM criteria [15], (2) previous sphincterotomy, (3) pancreatic head mass, and (4) routine biliary stent exchange. In case of a pancreatic duct intervention, chronic pancreatitis and previous sphincterotomy are not exclusion criteria
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Acute pancreatitis
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Altered anatomy, defined as anatomical variations in which bile and/or pancreatic secretions (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater (e.g., Roux-en-Y reconstruction, surgery for chronic pancreatitis)
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Pregnancy
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Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure
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Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation)
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Severe liver disease (cirrhosis and ascites)
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Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ERCP
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Hypotension (systolic blood pressure < 90 mmHg or mean arterial pressure < 70 mmHg)
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Hypo- or hypernatremia (serum Na+ levels < 130 or > 150 mmol/L)
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Contraindications for rectal NSAIDs, including allergy, active gastrointestinal bleeding, ulcer disease, renal insufficiency (glomerular filtration rate < 30 mL/min) and NSAID use for other indications (other than cardioprotective aspirin)
Treatment arms and co-interventions
Outcomes
Sample size calculation
Randomization
Blinding
Data collection methods and follow-up
Statistical methods
Descriptive statistics
Primary analysis
Additional analyses
Safety
Discussion
Trial status
Acknowledgements
Funding
Availability of data and materials
Authors’ information
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E.J.M. van Geenen, MD PhD, Department of Gastroenterology, Radboud University Medical Centre, Nijmegen (chair)
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J.P.H. Drenth, MD PhD, Department of Gastroenterology, Radboud University Medical Centre, Nijmegen
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P. Fockens, MD PhD, Department of Gastroenterology, Academic Medical Centre, Amsterdam
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C.J.J. Mulder, MD PhD, Department of Gastroenterology, VU Medical Centre, Amsterdam
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R. Timmer, MD PhD, Department of Gastroenterology, St. Antonius Hospital, Nieuwegein
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W. Kievit, MD PhD, Department of Health Evidence, Radboud University Medical Centre, Nijmegen
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M. Zegers, MD PhD, Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Centre, Nijmegen
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M.J. Bruno, MD PhD, Department of Gastroenterology, Erasmus MC University Medical Centre, Rotterdam
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M.G.H. Besselink, MD PhD, Department of Surgery, Academic Medical Centre, Amsterdam
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F. Vleggaar, MD PhD, Department of Gastroenterology, University Medical Centre Utrecht, Utrecht
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R.W.M. van der Hulst, MD PhD, Department of Gastroenterology, Spaarne Gasthuis, Haarlem
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A.C. Poen, MD PhD, Department of Gastroenterology, Isala Klinieken, Zwolle
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G.D.N. Heine, MD PhD, Department of Gastroenterology, Medical Centre Alkmaar, Alkmaar
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N.G. Venneman, MD PhD, Department of Gastroenterology, Medisch Spectrum Twente, Enschede
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J.J. Kolkman, MD PhD, Department of Gastroenterology, Medisch Spectrum Twente, Enschede
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L.C. Baak, MD PhD, Department of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam
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T.E.H. Römkens, MD PhD, Department of Gastroenterology, Jeroen Bosch hospital, Den Bosch
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E.J.M. van Geenen, MD PhD, Department of Gastroenterology, Radboud University Medical Centre, Nijmegen (chair)
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M.J. Bruno, MD PhD, Department of Gastroenterology, Erasmus MC University Medical Centre, Rotterdam
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P. Fockens, MD PhD, Department of Gastroenterology, Academic Medical Centre, Amsterdam
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B.J. Witteman, MD PhD, Department of Gastroenterology, Gelderse Vallei Hospital, Ede
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A.C. Poen, MD PhD, Department of Gastroenterology, Isala Clinics, Zwolle
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R.C. Verdonk, MD PhD, Department of Gastroenterology, St. Antonius Hospital, Nieuwegein
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T. Bollen, MD, Department of Radiology, St. Antonius Hospital, Nieuwegein
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F. Visser, MD PhD, Department of Nephrology, Ziekenhuisgroep Twente, Almelo
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R. Loffeld, MD PhD, Department of Gastroenterology and Hepatology, Zaans Medical Centre, Zaandam (chair)
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D. Burger, MD PhD, Department of Pharmacology, Radboud University Medical Centre, Nijmegen
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T. Nijenhuis, MD PhD, Department of Nephrology, Radboud University Medical Centre, Nijmegen
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M. Vaneker, MD PhD, Department of Anaesthesiology, Radboud University Medical Centre, Nijmegen
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D. de Jong, MD PhD, gastroenterologist at Radboud University Medical Centre, Nijmegen, The Netherlands (for all participating centres other than Radboud University Medical Centre)
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Al-Toma, MD PhD, gastroenterologist at St. Antonius hospital, Nieuwegein, The Netherlands (for the Radboud University Medical Centre)
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Principal investigators: E.J.M. van Geenen, MD PhD & J.P.H. Drenth, MD PhD, Department of Gastroenterology, Radboud University Medical Centre, Nijmegen, The Netherlands
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Coordinating investigator: X.J.N.M. Smeets, MD, Department of Gastroenterology, Radboud University Medical Centre, Nijmegen, The Netherlands