Aggressive intravenous hydration with lactated Ringer’s solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial

Chang Hwan Park, Woo Hyun Paik, Eun Taek Park, Chan Sup Shim, Tae Yoon Lee, Changdon Kang, Myung Hwan Noh, Sun Youn Yi, Jong Kyun Lee, Jong Jin Hyun, Jun Kyu Lee

Research output: Contribution to journalArticle

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Abstract

Background and study aims The present study aimed to determine the type of intravenous hydration that is best suited to reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Patients and methods In a prospective randomized multicenter trial, average-to-high risk patients who underwent first-time ERCP were randomly assigned to three groups (1:1:1) who received: aggressive intravenous hydration (3 mL/kg/h during ERCP, a 20-mL/kg bolus and 3 mL/kg/h for 8 hours after ERCP) with either lactated Ringer’s solution (LRS) or normal saline solution (NSS), or standard intravenous hydration with LRS (1.5 mL/kg/h during and for 8 hours after ERCP). The primary end point was post-ERCP pancreatitis (PEP). Results 395 patients were enrolled, and 385 completed the protocols. The three groups showed no significant differences in demographic characteristics. There was a significant difference in the intention-to-treat (ITT) PEP rate between the aggressive LRS group (3.0 %, 95 % confidence interval [CI] 0.1 % – 5.9 %; 4 /132), the aggressive NSS group (6.7 %, 95 %CI 2.5 % – 10.9 %; 9 /134) and the standard LRS group (11.6 %, 95 %CI 6.1 % – 17.2 %; 15 /129; P = 0.03). In the two-group comparisons, the ITT PEP rate was significantly lower for the aggressive LRS group than for the standard LRS group (relative risk [RR] 0.26, 95 %CI 0.08 – 0.76; P = 0.008). There was no significant difference in the ITT PEP rate between the aggressive NSS group and the standard LRS group (RR 0.57, 95 %CI 0.26 – 1.27; P = 0.17). Conclusion Aggressive hydration with LRS is the best approach to intravenous hydration for the prevention of PEP in average-to-high risk patients.

Original languageEnglish
JournalEndoscopy
DOIs
Publication statusAccepted/In press - 2017 Dec 13

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Endoscopic Retrograde Cholangiopancreatography
Pancreatitis
Multicenter Studies
Randomized Controlled Trials
Confidence Intervals
Sodium Chloride
Ringer's solution
Ringer's lactate
Demography

ASJC Scopus subject areas

  • Gastroenterology

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Aggressive intravenous hydration with lactated Ringer’s solution for prevention of post-ERCP pancreatitis : a prospective randomized multicenter clinical trial. / Park, Chang Hwan; Paik, Woo Hyun; Park, Eun Taek; Shim, Chan Sup; Lee, Tae Yoon; Kang, Changdon; Noh, Myung Hwan; Yi, Sun Youn; Lee, Jong Kyun; Hyun, Jong Jin; Lee, Jun Kyu.

In: Endoscopy, 13.12.2017.

Research output: Contribution to journalArticle

Park, Chang Hwan ; Paik, Woo Hyun ; Park, Eun Taek ; Shim, Chan Sup ; Lee, Tae Yoon ; Kang, Changdon ; Noh, Myung Hwan ; Yi, Sun Youn ; Lee, Jong Kyun ; Hyun, Jong Jin ; Lee, Jun Kyu. / Aggressive intravenous hydration with lactated Ringer’s solution for prevention of post-ERCP pancreatitis : a prospective randomized multicenter clinical trial. In: Endoscopy. 2017.
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title = "Aggressive intravenous hydration with lactated Ringer’s solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial",
abstract = "Background and study aims The present study aimed to determine the type of intravenous hydration that is best suited to reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Patients and methods In a prospective randomized multicenter trial, average-to-high risk patients who underwent first-time ERCP were randomly assigned to three groups (1:1:1) who received: aggressive intravenous hydration (3 mL/kg/h during ERCP, a 20-mL/kg bolus and 3 mL/kg/h for 8 hours after ERCP) with either lactated Ringer’s solution (LRS) or normal saline solution (NSS), or standard intravenous hydration with LRS (1.5 mL/kg/h during and for 8 hours after ERCP). The primary end point was post-ERCP pancreatitis (PEP). Results 395 patients were enrolled, and 385 completed the protocols. The three groups showed no significant differences in demographic characteristics. There was a significant difference in the intention-to-treat (ITT) PEP rate between the aggressive LRS group (3.0 {\%}, 95 {\%} confidence interval [CI] 0.1 {\%} – 5.9 {\%}; 4 /132), the aggressive NSS group (6.7 {\%}, 95 {\%}CI 2.5 {\%} – 10.9 {\%}; 9 /134) and the standard LRS group (11.6 {\%}, 95 {\%}CI 6.1 {\%} – 17.2 {\%}; 15 /129; P = 0.03). In the two-group comparisons, the ITT PEP rate was significantly lower for the aggressive LRS group than for the standard LRS group (relative risk [RR] 0.26, 95 {\%}CI 0.08 – 0.76; P = 0.008). There was no significant difference in the ITT PEP rate between the aggressive NSS group and the standard LRS group (RR 0.57, 95 {\%}CI 0.26 – 1.27; P = 0.17). Conclusion Aggressive hydration with LRS is the best approach to intravenous hydration for the prevention of PEP in average-to-high risk patients.",
author = "Park, {Chang Hwan} and Paik, {Woo Hyun} and Park, {Eun Taek} and Shim, {Chan Sup} and Lee, {Tae Yoon} and Changdon Kang and Noh, {Myung Hwan} and Yi, {Sun Youn} and Lee, {Jong Kyun} and Hyun, {Jong Jin} and Lee, {Jun Kyu}",
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T1 - Aggressive intravenous hydration with lactated Ringer’s solution for prevention of post-ERCP pancreatitis

T2 - a prospective randomized multicenter clinical trial

AU - Park, Chang Hwan

AU - Paik, Woo Hyun

AU - Park, Eun Taek

AU - Shim, Chan Sup

AU - Lee, Tae Yoon

AU - Kang, Changdon

AU - Noh, Myung Hwan

AU - Yi, Sun Youn

AU - Lee, Jong Kyun

AU - Hyun, Jong Jin

AU - Lee, Jun Kyu

PY - 2017/12/13

Y1 - 2017/12/13

N2 - Background and study aims The present study aimed to determine the type of intravenous hydration that is best suited to reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Patients and methods In a prospective randomized multicenter trial, average-to-high risk patients who underwent first-time ERCP were randomly assigned to three groups (1:1:1) who received: aggressive intravenous hydration (3 mL/kg/h during ERCP, a 20-mL/kg bolus and 3 mL/kg/h for 8 hours after ERCP) with either lactated Ringer’s solution (LRS) or normal saline solution (NSS), or standard intravenous hydration with LRS (1.5 mL/kg/h during and for 8 hours after ERCP). The primary end point was post-ERCP pancreatitis (PEP). Results 395 patients were enrolled, and 385 completed the protocols. The three groups showed no significant differences in demographic characteristics. There was a significant difference in the intention-to-treat (ITT) PEP rate between the aggressive LRS group (3.0 %, 95 % confidence interval [CI] 0.1 % – 5.9 %; 4 /132), the aggressive NSS group (6.7 %, 95 %CI 2.5 % – 10.9 %; 9 /134) and the standard LRS group (11.6 %, 95 %CI 6.1 % – 17.2 %; 15 /129; P = 0.03). In the two-group comparisons, the ITT PEP rate was significantly lower for the aggressive LRS group than for the standard LRS group (relative risk [RR] 0.26, 95 %CI 0.08 – 0.76; P = 0.008). There was no significant difference in the ITT PEP rate between the aggressive NSS group and the standard LRS group (RR 0.57, 95 %CI 0.26 – 1.27; P = 0.17). Conclusion Aggressive hydration with LRS is the best approach to intravenous hydration for the prevention of PEP in average-to-high risk patients.

AB - Background and study aims The present study aimed to determine the type of intravenous hydration that is best suited to reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Patients and methods In a prospective randomized multicenter trial, average-to-high risk patients who underwent first-time ERCP were randomly assigned to three groups (1:1:1) who received: aggressive intravenous hydration (3 mL/kg/h during ERCP, a 20-mL/kg bolus and 3 mL/kg/h for 8 hours after ERCP) with either lactated Ringer’s solution (LRS) or normal saline solution (NSS), or standard intravenous hydration with LRS (1.5 mL/kg/h during and for 8 hours after ERCP). The primary end point was post-ERCP pancreatitis (PEP). Results 395 patients were enrolled, and 385 completed the protocols. The three groups showed no significant differences in demographic characteristics. There was a significant difference in the intention-to-treat (ITT) PEP rate between the aggressive LRS group (3.0 %, 95 % confidence interval [CI] 0.1 % – 5.9 %; 4 /132), the aggressive NSS group (6.7 %, 95 %CI 2.5 % – 10.9 %; 9 /134) and the standard LRS group (11.6 %, 95 %CI 6.1 % – 17.2 %; 15 /129; P = 0.03). In the two-group comparisons, the ITT PEP rate was significantly lower for the aggressive LRS group than for the standard LRS group (relative risk [RR] 0.26, 95 %CI 0.08 – 0.76; P = 0.008). There was no significant difference in the ITT PEP rate between the aggressive NSS group and the standard LRS group (RR 0.57, 95 %CI 0.26 – 1.27; P = 0.17). Conclusion Aggressive hydration with LRS is the best approach to intravenous hydration for the prevention of PEP in average-to-high risk patients.

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