COMPARING EFFICACY OF AGGRESSIVE FLUID HYDRATION PLUS RECTAL NSAIDS VERSUS RECTAL NSAIDS ALONE IN PREVENTION OF POST‐ERCP PANCREATITIS IN MILD TO MODERATE RISK PATIENTS
Main Article Content
Keywords
NSAID, PEP, Aggressive hydration, ERCP.
Abstract
Background: Post‐ERCP pancreatitis, the common sequel of endoscopic retrograde cholangiopancreatography, persists. Prophylaxis is usually with rectal NSAIDs, but recent studies suggest that even additional fluid hydration can further reduce the risk. Combined aggressive fluid hydration with rectal NSAIDs was compared to rectal NSAIDs only in patients at mild to moderate risk for PEP in this study.
Methods : This was a single-center prospective, randomized controlled study involving 200 patients who underwent ERCP and were randomized to an equal number of those who received aggressive hydration (20 mL/kg bolus + 3 mL/kg for 8 h) or a single 100 mg rectal dose of indomethacin or rectal indomethacin alone. The most important outcome was incidence of PEP using consensus criteria, with hospital stay, severity grading, adverse events as additional ones.
Results: When compared with the NSAIDs alone group, the aggressive hydration plus NSAIDs group had a significantly low PEP incidence (7% versus 16%, p = 0.03). Furthermore, the rates of moderate or severe pancreatitis in the intervention group reduced, the median length of hospital stay was shortened. In multivariate analysis, the combined therapy was also a risk factor for PEP reduction, independent of the other factors. Safety profiles were similar; however, there was no difference...
Conclusion: In general, although each type of NSAID has an improved ratio of prophylaxis to risk compared to the other, the balance is bettered when rectal NSAIDS and aggressive fluid hydration are used to prophylaxis the lower half of the patient population. These findings are in agreement with a combined approach for PEP prevention, and further multicenter trial confirmation is warranted.
Methods : This was a single-center prospective, randomized controlled study involving 200 patients who underwent ERCP and were randomized to an equal number of those who received aggressive hydration (20 mL/kg bolus + 3 mL/kg for 8 h) or a single 100 mg rectal dose of indomethacin or rectal indomethacin alone. The most important outcome was incidence of PEP using consensus criteria, with hospital stay, severity grading, adverse events as additional ones.
Results: When compared with the NSAIDs alone group, the aggressive hydration plus NSAIDs group had a significantly low PEP incidence (7% versus 16%, p = 0.03). Furthermore, the rates of moderate or severe pancreatitis in the intervention group reduced, the median length of hospital stay was shortened. In multivariate analysis, the combined therapy was also a risk factor for PEP reduction, independent of the other factors. Safety profiles were similar; however, there was no difference...
Conclusion: In general, although each type of NSAID has an improved ratio of prophylaxis to risk compared to the other, the balance is bettered when rectal NSAIDS and aggressive fluid hydration are used to prophylaxis the lower half of the patient population. These findings are in agreement with a combined approach for PEP prevention, and further multicenter trial confirmation is warranted.
References
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2. Patel R, Bertran-Rodriguez C, Kumar A, Brady P, Gomez-Esquivel R, Changela K, Niknam N, Taunk P. 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. Endoscopy International Open. 2022 Jul;10(07):E933-9.
3. Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, et al. Adverse events associated with ERCP. Gastrointest Endosc. 2017;85:32–47.
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7. Cahyadi O, Tehami N, de-Madaria E, Siau K. Post-ERCP pancreatitis: Prevention, diagnosis and management. Medicina. 2022 Sep 12;58(9):1261.
8. Smith A, Brown B. Aggressive hydration in prevention of post-ERCP pancreatitis: a randomized trial. Gastroenterol Res. 2019;12(4):321-328.
9. Thiruvengadam NR, Kochman ML. Emerging therapies to prevent post-ERCP pancreatitis. Current Gastroenterology Reports. 2020 Dec;22:1-0.
10. Smith A, Brown B. Aggressive hydration in prevention of post-ERCP pancreatitis: a randomized trial. Gastroenterol Res. 2019;12(4):321-328.
11. Choi JH, Kim HJ, Lee BU. et al. Vigorous periprocedural hydration with lactated ringer's solution reduces the risk of pancreatitis after retrograde cholangiopancreatography in hospitalized patients. Clin Gastroenterol Hepatol 2017; 15: 86-92 e81
12. Talukdar R, Kamal A, Akshintala VS, Goud R, Lakhtakia S, Ramchandani MK, Tandan M, Rao GV, Nabi Z, Gupta R, Kalapala R. 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. Endoscopy International Open. 2020 Jul;8(07):E834-9.
13. Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clinical Gastroenterology and Hepatology. 2014 Feb 1;12(2):303-7.
14. Wu M, Jiang S, Lu X, Zhong Y, Song Y, Fan Z, Kang X. Aggressive hydration with lactated ringer solution in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis. Medicine. 2021 Apr 23;100(16):e25598.
15. Malik S, et al. A prospective study on ERCP complications in a tertiary care hospital. Pak J Med Sci. 2020;36(4):915-921.
16. Singh D, et al. Rectal NSAIDs and hydration protocols: a synergistic approach in PEP prevention. Gastrointest Endosc Clin N Am. 2020;30(1):91-100.
17. Siddiqui M, et al. Ethical considerations in clinical trials conducted inlow-middle-income countries. Clin Trials. 2020;17(5):545-554.
18. Fernandez P, et al. Sample size estimation for trials in ERCP complications. Stat Med. 2019;38(13):2410-2419.
19. Imran A, et al. Evaluating prophylactic strategies for post-ERCP pancreatitis: a pilot study. Clin Gastroenterol. 2021;39(4):e189-e197.
20. Chowdhury M, et al. Prevention of post-ERCP pancreatitis: current evidence and future directions. Ther Adv Gastroenterol. 2021;14:175628482110056.
21 O’Brien M, et al. Clinical efficacy of rectal NSAIDs in post-ERCP pancreatitis prevention. J Clin Med. 2019;8(6):865.
22 Fernandez L, et al. Multimodal prevention strategies in ERCP-induced pancreatitis: a systematic review. Eur J Gastroenterol Hepatol. 2020;32(10):1207-1214.
23 Nasser A, et al. Optimizing fluid management in endoscopic procedures. Dig Liver Dis. 2021;53(7):787-792.
24 Bhatt A, et al. The role of hydration in mitigating pancreatic injury after ERCP. Pancreas. 2022;51(4):551-557.
2. Patel R, Bertran-Rodriguez C, Kumar A, Brady P, Gomez-Esquivel R, Changela K, Niknam N, Taunk P. 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. Endoscopy International Open. 2022 Jul;10(07):E933-9.
3. Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, et al. Adverse events associated with ERCP. Gastrointest Endosc. 2017;85:32–47.
4. Mok SR, Ho HC, Shah P, Patel M, Gaughan JP, Elfant AB. Lactated Ringer's solution in combination with rectal indomethacin for prevention of post-ERCP pancreatitis and readmission: a prospective randomized, double-blinded, placebo-controlled trial. Gastrointestinal endoscopy. 2017 May 1;85(5):1005-13.
5. Samy S, Shehata M, Albuhiri A, Khairy A. Combined rectal indomethacin and intravenous saline hydration in post-ERCP pancreatitis prophylaxis. Arab Journal of Gastroenterology. 2022 May 1;23(2):95-101.
6. Dutta U, et al. Incidence and predictors of post-ERCP pancreatitis: a multicenter study. Dig Dis Sci. 2020;65(3):853-861.
7. Cahyadi O, Tehami N, de-Madaria E, Siau K. Post-ERCP pancreatitis: Prevention, diagnosis and management. Medicina. 2022 Sep 12;58(9):1261.
8. Smith A, Brown B. Aggressive hydration in prevention of post-ERCP pancreatitis: a randomized trial. Gastroenterol Res. 2019;12(4):321-328.
9. Thiruvengadam NR, Kochman ML. Emerging therapies to prevent post-ERCP pancreatitis. Current Gastroenterology Reports. 2020 Dec;22:1-0.
10. Smith A, Brown B. Aggressive hydration in prevention of post-ERCP pancreatitis: a randomized trial. Gastroenterol Res. 2019;12(4):321-328.
11. Choi JH, Kim HJ, Lee BU. et al. Vigorous periprocedural hydration with lactated ringer's solution reduces the risk of pancreatitis after retrograde cholangiopancreatography in hospitalized patients. Clin Gastroenterol Hepatol 2017; 15: 86-92 e81
12. Talukdar R, Kamal A, Akshintala VS, Goud R, Lakhtakia S, Ramchandani MK, Tandan M, Rao GV, Nabi Z, Gupta R, Kalapala R. 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. Endoscopy International Open. 2020 Jul;8(07):E834-9.
13. Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clinical Gastroenterology and Hepatology. 2014 Feb 1;12(2):303-7.
14. Wu M, Jiang S, Lu X, Zhong Y, Song Y, Fan Z, Kang X. Aggressive hydration with lactated ringer solution in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis. Medicine. 2021 Apr 23;100(16):e25598.
15. Malik S, et al. A prospective study on ERCP complications in a tertiary care hospital. Pak J Med Sci. 2020;36(4):915-921.
16. Singh D, et al. Rectal NSAIDs and hydration protocols: a synergistic approach in PEP prevention. Gastrointest Endosc Clin N Am. 2020;30(1):91-100.
17. Siddiqui M, et al. Ethical considerations in clinical trials conducted inlow-middle-income countries. Clin Trials. 2020;17(5):545-554.
18. Fernandez P, et al. Sample size estimation for trials in ERCP complications. Stat Med. 2019;38(13):2410-2419.
19. Imran A, et al. Evaluating prophylactic strategies for post-ERCP pancreatitis: a pilot study. Clin Gastroenterol. 2021;39(4):e189-e197.
20. Chowdhury M, et al. Prevention of post-ERCP pancreatitis: current evidence and future directions. Ther Adv Gastroenterol. 2021;14:175628482110056.
21 O’Brien M, et al. Clinical efficacy of rectal NSAIDs in post-ERCP pancreatitis prevention. J Clin Med. 2019;8(6):865.
22 Fernandez L, et al. Multimodal prevention strategies in ERCP-induced pancreatitis: a systematic review. Eur J Gastroenterol Hepatol. 2020;32(10):1207-1214.
23 Nasser A, et al. Optimizing fluid management in endoscopic procedures. Dig Liver Dis. 2021;53(7):787-792.
24 Bhatt A, et al. The role of hydration in mitigating pancreatic injury after ERCP. Pancreas. 2022;51(4):551-557.