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
Abstract 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 drawbac...
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| Format: | Article |
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BMC
2018-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2583-x |
| _version_ | 1819076126176182272 |
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| author | Xavier J. N. M. Smeets David W. da Costa Paul Fockens Chris J. J. Mulder Robin Timmer Wietske Kievit Marieke Zegers Marco J. Bruno Marc G. H. Besselink Frank P. Vleggaar Rene W. M. van der Hulst Alexander C. Poen Gerbrand D. N. Heine Niels G. Venneman Jeroen J. Kolkman Lubbertus C. Baak Tessa E. H. Römkens Sven M. van Dijk Nora D. L. Hallensleben Wim van de Vrie Tom C. J. Seerden Adriaan C. I. T. L. Tan Annet M. C. J. Voorburg Jan-Werner Poley Ben J. Witteman Abha Bhalla Muhammed Hadithi Willem J. Thijs Matthijs P. Schwartz Jan Maarten Vrolijk Robert C. Verdonk Foke van Delft Yolande Keulemans Harry van Goor Joost P. H. Drenth Erwin J. M. van Geenen for the Dutch Pancreatitis Study Group |
| author_facet | Xavier J. N. M. Smeets David W. da Costa Paul Fockens Chris J. J. Mulder Robin Timmer Wietske Kievit Marieke Zegers Marco J. Bruno Marc G. H. Besselink Frank P. Vleggaar Rene W. M. van der Hulst Alexander C. Poen Gerbrand D. N. Heine Niels G. Venneman Jeroen J. Kolkman Lubbertus C. Baak Tessa E. H. Römkens Sven M. van Dijk Nora D. L. Hallensleben Wim van de Vrie Tom C. J. Seerden Adriaan C. I. T. L. Tan Annet M. C. J. Voorburg Jan-Werner Poley Ben J. Witteman Abha Bhalla Muhammed Hadithi Willem J. Thijs Matthijs P. Schwartz Jan Maarten Vrolijk Robert C. Verdonk Foke van Delft Yolande Keulemans Harry van Goor Joost P. H. Drenth Erwin J. M. van Geenen for the Dutch Pancreatitis Study Group |
| author_sort | Xavier J. N. M. Smeets |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-21T18:36:21Z |
| format | Article |
| id | doaj.art-ef5e1e40d00045869121dc4813bfc938 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T18:36:21Z |
| publishDate | 2018-04-01 |
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| series | Trials |
| spelling | doaj.art-ef5e1e40d00045869121dc4813bfc9382022-12-21T18:54:09ZengBMCTrials1745-62152018-04-011911910.1186/s13063-018-2583-xFluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trialXavier J. N. M. Smeets0David W. da Costa1Paul Fockens2Chris J. J. Mulder3Robin Timmer4Wietske Kievit5Marieke Zegers6Marco J. Bruno7Marc G. H. Besselink8Frank P. Vleggaar9Rene W. M. van der Hulst10Alexander C. Poen11Gerbrand D. N. Heine12Niels G. Venneman13Jeroen J. Kolkman14Lubbertus C. Baak15Tessa E. H. Römkens16Sven M. van Dijk17Nora D. L. Hallensleben18Wim van de Vrie19Tom C. J. Seerden20Adriaan C. I. T. L. Tan21Annet M. C. J. Voorburg22Jan-Werner Poley23Ben J. Witteman24Abha Bhalla25Muhammed Hadithi26Willem J. Thijs27Matthijs P. Schwartz28Jan Maarten Vrolijk29Robert C. Verdonk30Foke van Delft31Yolande Keulemans32Harry van Goor33Joost P. H. Drenth34Erwin J. M. van Geenen35for the Dutch Pancreatitis Study GroupDepartment of Gastroenterology and Hepatology, Radboud University Medical CentreDepartment of Radiology, St Antonius HospitalDepartment of Gastroenterology and Hepatology, Academic Medical CentreDepartment of Gastroenterology and Hepatology, VU University Medical Centre AmsterdamDepartment of Gastroenterology and Hepatology, St Antonius HospitalDepartment of Health Evidence, Radboud University Medical CentreRadboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical CentreDepartment of Gastroenterology and Hepatology, Erasmus Medical CentreDepartment of Surgery, Academic Medical CentreDepartment of Gastroenterology and Hepatology, University Medical Centre UtrechtDepartment of Gastroenterology and Hepatology, Spaarne GasthuisDepartment of Gastroenterology and Hepatology, Isala KliniekenDepartment of Gastroenterology and Hepatology, Noord-West HospitalDepartment of Gastroenterology and Hepatology, Medisch Spectrum TwenteDepartment of Gastroenterology and Hepatology, Medisch Spectrum TwenteDepartment of Gastroenterology and Hepatology, Onze Lieve Vrouwe GasthuisDepartment of Gastroenterology and Hepatology, Jeroen Bosch HospitalDepartment of Surgery, Academic Medical CentreDepartment of Gastroenterology and Hepatology, Erasmus Medical CentreDepartment of Gastroenterology and Hepatology, Albert Schweitzer HospitalDepartment of Gastroenterology and Hepatology, Amphia HospitalDepartment of Gastroenterology and Hepatology, Canisius-Wilhelmina HospitalDepartment of Gastroenterology and Hepatology, DiakonessenhuisDepartment of Gastroenterology and Hepatology, Erasmus Medical CentreDepartment of Gastroenterology and Hepatology, Hospital Gelderse ValleiDepartment of Gastroenterology and Hepatology, HAGA HospitalDepartment of Gastroenterology and Hepatology, Maasstad HospitalDepartment of Gastroenterology and Hepatology, Martini HospitalDepartment of Gastroenterology and Hepatology, Meander Medical CentreDepartment of Gastroenterology and Hepatology, Rijnstate HospitalDepartment of Gastroenterology and Hepatology, St Antonius HospitalDepartment of Gastroenterology and Hepatology, VU University Medical Centre AmsterdamDepartment of Gastroenterology and Hepatology, ZuyderlandDepartment of Surgery, Radboud University Medical CentreDepartment of Gastroenterology and Hepatology, Radboud University Medical CentreDepartment of Gastroenterology and Hepatology, Radboud University Medical CentreAbstract 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.http://link.springer.com/article/10.1186/s13063-018-2583-xPost-ERCP pancreatitisPreventionERCPHydrationNSAIDs |
| spellingShingle | Xavier J. N. M. Smeets David W. da Costa Paul Fockens Chris J. J. Mulder Robin Timmer Wietske Kievit Marieke Zegers Marco J. Bruno Marc G. H. Besselink Frank P. Vleggaar Rene W. M. van der Hulst Alexander C. Poen Gerbrand D. N. Heine Niels G. Venneman Jeroen J. Kolkman Lubbertus C. Baak Tessa E. H. Römkens Sven M. van Dijk Nora D. L. Hallensleben Wim van de Vrie Tom C. J. Seerden Adriaan C. I. T. L. Tan Annet M. C. J. Voorburg Jan-Werner Poley Ben J. Witteman Abha Bhalla Muhammed Hadithi Willem J. Thijs Matthijs P. Schwartz Jan Maarten Vrolijk Robert C. Verdonk Foke van Delft Yolande Keulemans Harry van Goor Joost P. H. Drenth Erwin J. M. van Geenen for the Dutch Pancreatitis Study Group 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 Post-ERCP pancreatitis Prevention ERCP Hydration NSAIDs |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Post-ERCP pancreatitis Prevention ERCP Hydration NSAIDs |
| url | http://link.springer.com/article/10.1186/s13063-018-2583-x |
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