Christa Sperna Weiland, Xavier Smeets, Erwin van Geenen, Joost Drenth, theme Renal disorders and colleagues published in The Lancet Gastroenterology & Hepatology a multicentre, open-label, randomised, controlled trial to evaluate aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT).
Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk. Guidelines already recommend aggressive hydration in patients who are unable to receive rectal NSAIDs, although it is laborious and time consuming. We aimed to evaluate the added value of aggressive hydration in patients receiving prophylactic rectal NSAIDs.
FLUYT, a multicentre, open-label, randomised, controlled superiority trial done across 22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis. Patients were randomly assigned (1:1) by a web-based module with varying block sizes to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group). Randomisation was stratified according to treatment centre. Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from the start of ERCP, followed by 3 mL/kg per h for 8 h. The control group received normal intravenous saline with a maximum of 1.5 mL/kg per h and 3 L per 24 h. The primary endpoint was post-ERCP pancreatitis and was analysed on a modified intention-to-treat basis (including all patients who underwent randomisation and an ERCP and for whom data regarding the primary outcome were available). The trial is registered with the ISRCTN registry, ISRCTN13659155.
Between June 5, 2015, and June 6, 2019, 826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and in 39 (9%) patients in the control group (relative risk 0.84, 95% CI 0.53-1.33, p=0.53). There were no differences in serious adverse events, including hydration-related complications (relative risk 0.99, 95% CI 0.59-1.64; p=1.00), ERCP-related complications (0.90, 0.62-1.31; p=0.62), intensive care unit admission (0.37, 0.07-1.80; p=0.22), and 30-day mortality (0.95, 0.50-1.83; p=1.00).
Aggressive periprocedural hydration did not reduce the incidence of post-ERCP pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal NSAIDs. Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified.
Related news items
New ultra-high field MRI system available for Radboudumc and Radboud University10 June 2021
Recently, the Hahn institute in Essen has received a new heart: a 20-ton ultra-high-field MRI scanner from Siemens Healthcare with a magnetic field strength of 7 Tesla. The new CE-approved scanner is ready for business, and projects on body and brain imaging are starting up.read more
On the prevalence of cerebral amyloid angiopathy a systematic review and meta-analysis10 June 2021
Published in ‘Alzheimers and Dementia’, researchers at Radboudumc performed a systematic review and meta-analysis on the prevalence of Cerebral Amyloid Angiopathy. They scrutinized and analyzed 170 publications, comprising publications using either a neuroimaging or a neuropathological approach.read more
Retina-on-chip modeling and treating eye diseases in a dish10 June 2021
Alex Garanto, together with Anneke den Hollander and Andries van der Meer (UTwente) have received 1,17M€ to develop a retina-on-chip model to improve our understanding in eye diseases and to develop treatments against them.read more
A tipping point in cancer-immune dynamics leads to divergent immunotherapy responses8 June 2021
Jeroen Creemers and Johannes Textor published in the Journal for ImmunoTherapy of Cancer that a tipping point in cancer-immune dynamics leads to divergent immunotherapy responses and hampers biomarker discovery.read more
New method to prevent ovarian cancer increases quality of life8 June 2021
Researchers at Radboudumc have shown that quality of life is better in women with a BRCA1 or BRCA2 mutation after fallopian tube removal with delayed ovarian removal to prevent ovarian cancer.read more