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Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis

Pancreatic Disease Clinical Trial

Official title:
Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis : Multicenter, Double Blind, Randomized Controlled Trial

Clinical Trial Summary

In the existing Aggressive hydration comparison study related to the prevention of post-ERCP pancreatitis (PEP), research bias may occur due to the lack of blinding between fluids, so in this study, the investigators will conduct a multicenter randomized comparative study in which the comparative fluids are double-blinded to observe differences between fluids in the preventive effect of pancreatitis that occurs after ERCP (endoscopic retrograde cholangiopancreatography). A total of 844 patients scheduled for ERCP will be enrolled in this clinical trial and randomly assigned to the lactated Ringer's solution or to the Plasma solution in a 1:1 ratio. Eligible patients will receive study drug or control drug for up to 24 hours before and after ERCP implementation.

Clinical Trial Description

Post-ERCP pancreatitis (PEP), which occurs in 2% to 15% of all patients undergoing ERCP and is treated conservatively with fasting and sufficient fluid supply according to the standards of care for general acute pancreatitis, and most patients improve within a few days without major complications. However, high-risk patients are more susceptible to PEP with incidence rates between 15% and 42%, and severe pancreatitis can develop in 11.4% of PEP cases with a 3% mortality rate. Therefore, there are significant unmet needs for PEP patients. In this trial, all patients will receive aggressive hydration involving fluids that are commercially available and widely administered. The trial aims to minimize potential risks and has established routine safety monitoring to protect the participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05832047
Study type Interventional
Source Asan Medical Center
Contact Eun Ha Kim
Phone 82 2 3010 5739
Email sp98rn@gmail.com
Status Recruiting
Phase Phase 4
Start date June 19, 2023
Completion date September 2024
View Details
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