Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP Pancreatitis

NCT05832047 PHASE4 COMPLETED

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. In previous comparative studies related to PEP prevention, research bias may have been introduced because of insufficient blinding of the treatment strategies, as well as instances where the evaluating investigator did not perform blinding. We are therefore conducting a multicenter, randomized comparative study double-blinded as to the two types of fluid (lactated Ringer's solution or plasma solution), and in which the endoscopists, outcome assessors and patients are blinded to the randomization allocation.

Details

Lead sponsor	Do Hyun Park
Phase	PHASE4
Status	COMPLETED
Enrolment	844
Start date	Mon Jun 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Jan 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Pancreatic Disease

Interventions

• Plasma solution (4-hour aggressive hydration)
• Lactated Ringer solution (4-hour aggressive hydration)
• 8-hour aggressive hydration

Countries

South Korea