Endoscopy 2021; 53(S 01): S26-S27
DOI: 10.1055/s-0041-1724323
Abstracts | ESGE Days
ESGE Days 2021 Oral presentations
Thursday, 25 March 2021 17:00 – 17:45 ERCP: What to do when things go wrong Room 6

A Randomised Trial of Aggressive Fluid Hydration to Prevent Post-ERCP Pancreatitis (FLUYT)

Authors

  • CJ Sperna Weiland

    1   Radboudumc, Gastroenterology and Hepatology, Nijmegen, Netherlands
    2   St. Antonius Ziekenhuis, Research and Development, Nieuwegein, Netherlands

  • XJ Smeets

    1   Radboudumc, Gastroenterology and Hepatology, Nijmegen, Netherlands
    2   St. Antonius Ziekenhuis, Research and Development, Nieuwegein, Netherlands

  • W Kievit

    1   Radboudumc, Gastroenterology and Hepatology, Nijmegen, Netherlands

  • RC Verdonk

    3   St. Antonius Ziekenhuis, Gastroenterology and Hepatology, Nieuwegein, Netherlands

  • AC Poen

    4   Isala Clinics, Gastroenterology and Hepatology, Zwolle, Netherlands

  • A Bhalla

    5   Hagaziekenhuis, Gastroenterology and Hepatology, Den Haag, Netherlands

  • NG Venneman

    6   Medisch Spectrum Twente, Gastroenterology and Hepatology, Enschede, Netherlands

  • BJ Witteman

    7   Gelderse Vallei Ziekenhuis, Gastroenterology and Hepatology, Ede, Netherlands

  • DW da Costa

    8   St. Antonius Ziekenhuis, Radiology, Nieuwegein, Netherlands

  • B van Eijck

    9   Spaarne Gasthuis, Gastroenterology and Hepatology, Hoofddorp, Netherlands

  • MP Schwartz

    10   Meander Medical Centre, Gastroenterology and Hepatology, Amersfoort, Netherlands

  • TE Römkens

    11   Jeroen Bosch Ziekenhuis, Gastroenterology and Hepatology, Den Bosch, Netherlands

  • JM Vrolijk

    12   Rijnstate Ziekenhuis, Gastroenterology and Hepatology, Arnhem, Netherlands

  • M Hadithi

    13   Maasstad Ziekenhuis, Gastroenterology and Hepatology, Rotterdam, Netherlands

  • AM Voorburg

    14   Diakonessenhuis, Gastroenterology and Hepatology, Utrecht, Netherlands

  • LC Baak

    15   OLVG, Gastroenterology and Hepatology, Amsterdam, Netherlands

  • WJ Thijs

    16   Martini Ziekenhuis, Gastroenterology and Hepatology, Groningen, Netherlands

  • RL van Wanrooij

    17   AmsterdamUMC, Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, Netherlands

  • AC Tan

    18   Canisius Wilhelmina Ziekenhuis, Gastroenterology and Hepatology, Nijmegen, Netherlands

  • TC Seerden

    19   Amphia Ziekenhuis, Gastroenterology and Hepatology, Breda, Netherlands

  • YC Keulemans

    20   Zuyderland Ziekenhuis, Gastroenterology and Hepatology, Heerlen, Netherlands

  • TR de Wijkerslooth

    21   Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Gastroenterology and Hepatology, Amsterdam, Netherlands

  • W van de Vrie

    22   Albert Schweitzer Ziekenhuis, Gastroenterology and Hepatology, Dordrecht, Netherlands

  • P van der Schaar

    3   St. Antonius Ziekenhuis, Gastroenterology and Hepatology, Nieuwegein, Netherlands

  • SM van Dijk

    23   AmsterdamUMC, Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, Netherlands
    24   St. Antonius ziekenhuis, Research and Development, Nieuwegein, Netherlands

  • ND Hallensleben

    25   Erasmus Medical Centre, Anaesthesiology, Rotterdam, Netherlands
    2   St. Antonius Ziekenhuis, Research and Development, Nieuwegein, Netherlands

  • RL Sperna Weiland

    26   University of Amsterdam, Amsterdam, Netherlands

  • HC Timmerhuis

    2   St. Antonius Ziekenhuis, Research and Development, Nieuwegein, Netherlands

  • DS Umans

    17   AmsterdamUMC, Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, Netherlands
    2   St. Antonius Ziekenhuis, Research and Development, Nieuwegein, Netherlands

  • JE van Hooft

    17   AmsterdamUMC, Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, Netherlands
    27   Leiden University Medical Centre, Gastroenterology and Hepatology, Leiden, Netherlands

  • H van Goor

    28   Radboudumc, Surgery, Nijmegen, Netherlands

  • HC van Santvoort

    29   St. Antonius Ziekenhuis, Surgery, Nieuwegein, Netherlands
    30   Utrecht University Medical Centre, Surgery, Utrecht, Netherlands

  • MG Besselink

    23   AmsterdamUMC, Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, Netherlands

  • MJ Bruno

    31   Erasmus Medical Centre, Gastroenterology and Hepatology, Rotterdam, Netherlands

  • P Fockens

    17   AmsterdamUMC, Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, Netherlands

  • JP Drenth

    1   Radboudumc, Gastroenterology and Hepatology, Nijmegen, Netherlands

  • EJ van Geenen

    1   Radboudumc, Gastroenterology and Hepatology, Nijmegen, Netherlands
    • Dutch Pancreatitis Study Group
Further Information
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Aims Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (rNSAIDs) administration is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration may further reduce this risk. Guidelines already recommend aggressive hydration. However, multicentre randomised trials studying the added value of aggressive hydration in patients receiving prophylactic rNSAIDs are lacking. We, therefore, performed a trial to investigate the combination of aggressive hydration and rNSAIDs.

Methods In this multicentre, parallel-group open-label randomised controlled superiority trial, patients with moderate- to high-risk of post-ERCP pancreatitis were assessed for eligibility in 22 Dutch hospitals. Patients were randomly assigned (1:1) to a combination of aggressive hydration and rNSAIDs or rNSAIDs monotherapy. Aggressive hydration comprised 20mL/kg lactated Ringer’s intravenously from the start of ERCP within 60 minutes, followed by 3mL/kg/h for 8 hours. The control group received normal saline with a maximum of 1.5mL/kg/h and 3L/24h. The primary endpoint was post-ERCP pancreatitis. Secondary endpoints included pancreatitis severity and ERCP- and hydration-related complications. ISRCTN registry: ISRCTN13659155.

Results A total of 826 patients were randomised. Patient baseline and ERCP characteristics were similar in both groups. Post-ERCP pancreatitis developed in 30 of 388 patients (8 %) in the hydration group and in 39 of 425 patients (9 %) in the control group (RR, 0.84; 95 %CI [0.53-1.33]; P = 0.53). 21 patients (5 %) in the hydration group and in 32 patients (8 %) in the control group (P = 0.39) developed a moderate-to-severe pancreatitis. ERCP- and hydration-related complications did not differ between both groups (P = 0.6 and P = 1.0, respectively). There were no differences in other secondary endpoints, including serious adverse events.

Conclusions The combination of rNSAIDs and aggressive periprocedural hydration was not superior in reducing the incidence of post-ERCP pancreatitis, as compared to rNSAID monotherapy in patients with moderate- to high- risk of post-ERCP pancreatitis.

Citation: Sperna Weiland CJ, Smeets XJ, Kievit W et al. OP63 A RANDOMISED TRIAL OF AGGRESSIVE FLUID HYDRATION TO PREVENT POST-ERCP PANCREATITIS (FLUYT). Endoscopy 2021; 53: S26.



Publication History

Article published online:
19 March 2021

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