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Endoscopy 2018; 50(04): 378-385
DOI: 10.1055/s-0043-122386
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Chang-Hwan Park
1   Department of Internal Medicine, Chonnam National University Medical School, Gwangju, South Korea
,
Woo Hyun Paik
2   Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
,
Eun Taek Park
3   Department of Internal Medicine, Gospel Hospital, University of Kosin College of Medicine, Busan, South Korea
,
Chan Sup Shim
4   Digestive Disease Center, Konkuk University School of Medicine, Seoul, South Korea
,
Tae Yoon Lee
4   Digestive Disease Center, Konkuk University School of Medicine, Seoul, South Korea
,
Changdon Kang
5   Department of Internal Medicine, School of Medicine, Kangwon National University, Kangwon, South Korea
,
Myung Hwan Noh
6   Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea
,
Sun Youn Yi
7   Department of Internal Medicine, School of Medicine, Ewha Woman’s University, Seoul, South Korea
,
Jong Kyun Lee
8   Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
,
Jong Jin Hyun
9   Department of Medicine, Korea University Ansan Hospital, Seoul, South Korea
,
Jun Kyu Lee
10   Dongguk University Ilsan Hospital, Goyang, South Korea
› Author AffiliationsTRIAL REGISTRATION: Prospective Randomized Multi-Center Trial KCT0001398 at https://cris.nih.go.kr/cris
Further Information

Publication History

submitted 28 May 2017

accepted after revision 25 September 2017

Publication Date:
13 December 2017 (online)

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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.

 

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