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DOI: 10.1055/a-1834-6568
Efficacy of aggressive hydration with normal saline versus lactated Ringer’s solution for the prevention of post-ERCP pancreatitis in high-risk patients: a randomized controlled trial
TRIAL REGISTRATION: Randomized blinded controlled trial at http://www.clinicaltrials.gov/Abstract
Background and study aims Post-ERCP pancreatitis (PEP) is a common adverse event in high-risk patients. Current intervention known to reduce the incidence and severity of PEP include pancreatic duct stent placement, nonsteroidal anti-inflammatory drugs per rectum, and intravenous (IV) fluids. We compared aggressive normal saline (NS) vs aggressive lactated Ringer’s (LR) infusion for the prevention of PEP in high-risk patients undergoing ERCP.
Patients and methods Patients were randomized to receive either an aggressive infusion of NS or LR. The infusion was started at a rate of 3 mL/kg/hr and continued throughout the ERCP procedure. A 20 mL/kg bolus was given at the end of the procedure, then continued at a rate of 3 mL/kg/hr.
Results A total of 136 patients were included in our analysis. The incidence of PEP was 4 % (3/72 patients) in the LR group versus 11 % (7/64 patients) in the NS group resulting in a relative risk (RR) of 0.38 (95 % confidence interval [CI] 0.10 to 1.42; P = 0.19). The relative risk reduction (RRR) was 0.62 (95 % CI –0.41 to 0.90) along with an absolute risk reduction (ARR) of 0.07 (95 % CI –0.025 to 0.17) and an number needed to treat of 15 (95 % CI –41 to 6).
Conclusions To our knowledge, this is the first study comparing aggressive IV NS to aggressive IV LR in high-risk patients. The incidence of PEP was lower in the group receiving an aggressive LR infusion (4 %) compared to NS infusion (11 %). However, the difference was not statistically significant likely due to poor accrual thereby impacting the power of the study.
Publication History
Received: 15 July 2021
Accepted after revision: 25 April 2022
Accepted Manuscript online:
25 April 2022
Article published online:
15 July 2022
© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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References
- 1 Kochar B, Akshintala VS, Afghani E. et al. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc 2015; 81: 143-149.e149
- 2 Dumonceau JM, Kapral C, Aabakken L. et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2020; 52: 127-149
- 3 Haseeb A, Freeman ML. Guidewire in the pancreatic duct: key to risk and rescue for post-ERCP pancreatitis. Gastrointest Endosc 2019; 89: 309-310
- 4 Shin SH, So H, Cho S. et al. The number of wire placement in the pancreatic duct and metal biliary stent as risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis. J Gastroenterol Hepatol 2020; 35: 1201-1207
- 5 Boskoski I, Costamagna G. How to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis. Gastroenterology 2020; 158: 2037-2040
- 6 Arain MA, Freeman ML. Pancreatic stent placement remains a cornerstone of prevention of post-ERCP pancreatitis, but it requires specialized techniques. Gastrointest Endosc 2015; 81: 156-158
- 7 Elmunzer BJ, Scheiman JM, Lehman GA. et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med 2012; 366: 1414-1422
- 8 Wu D, Wan J, Xia L. et al. The efficiency of aggressive hydration with lactated ringer solution for the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis. J Clin Gastroenterol 2017; 51: e68-e76
- 9 Chandrasekhara V, Khashab MA, Muthusamy VR. et al. Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32-47
- 10 Tenner S, Baillie J, DeWitt J. et al. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol 2013; 108: 1400-1415
- 11 Radadiya D, Devani K, Arora S. et al. Peri-procedural aggressive hydration for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis prophylaxsis: meta-analysis of randomized controlled trials. Pancreatology 2019; 19: 819-827
- 12 Wang RC, Jiang ZK, Xie YK. et al. Aggressive hydration compared to standard hydration with lactated ringerʼs solution for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Surg Endosc 2021; 35: 1126-1137
- 13 Talukdar R, Kamal A, Akshintala VS. et al. Fluid type and volume reduce risk of post-ERCP pancreatitis and length of hospital stay in high-risk patients: a secondary analysis of the INDIEH trial. Endosc Int Open 2020; 8: E834-E839
- 14 Mok SRS, Ho HC, Shah P. et al. Lactated Ringerʼs solution in combination with rectal indomethacin for prevention of post-ERCP pancreatitis and readmission: a prospective randomized, double-blinded, placebo-controlled trial. Gastrointest Endosc 2017; 85: 1005-1013
- 15 Park CH, Paik WH, Park ET. et al. Aggressive intravenous hydration with lactated Ringerʼs solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy 2018; 50: 378-385
- 16 Patel R, Kumar A, Gomez Esquivel R. et al. Tu1422 High volume peri-procedural lactated ringer’s and normal saline are equally effective in preventing post-ERCP pancreatitis. Gastrointest Endosc 2018; 87: AB591
- 17 Buxbaum J, Yan A, Yeh K. et al. Aggressive hydration with lactated Ringerʼs solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol 2014; 12: 303-307.e301
- 18 Shaygan-Nejad A, Masjedizadeh AR, Ghavidel A. et al. Aggressive hydration with Lactated Ringerʼs solution as the prophylactic intervention for postendoscopic retrograde cholangiopancreatography pancreatitis: A randomized controlled double-blind clinical trial. J Res Med Sci 2015; 20: 838-843
- 19 Sperna Weiland CJ, Smeets X, Kievit W. et al. Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial. Lancet Gastroenterol Hepatol 2021; 6: 350-358