Study Comparing Aggressive Intravenous Hydration Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy

What this Trial Is About

Researchers are evaluating whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after pancreatic Extracorporeal Shock Wave Lithotripsy ESWL compared to using indometacin alone. This multicenter, randomized, controlled trial focuses on patients with painful chronic pancreatitis who are scheduled for ESWL to treat pancreatic duct stones. The study aims to improve understanding of pancreatitis prevention following ESWL and reduce related complications. Participants will be randomly assigned to one of two groups. One group will receive a rectal administration of 100mg indometacin 30 minutes before ESWL along with aggressive intravenous hydration using lactated Ringers solution, delivered as 20 mLkg within 60 minutes from the start of ESWL followed by 3 mLkg per hour for 8 hours. The other group will receive the same indometacin dose but only restricted hydration measures without aggressive intravenous fluids. Both interventions are carefully monitored during the procedure. During the trial, researchers will measure the incidence of pancreatitis within 24 hours after ESWL as the primary outcome. Additional assessments include severity of pancreatitis, incidence of other post-ESWL complications, fluid overload, transient adverse events within 24 hours, and length of hospitalization over one month. Participants will be evaluated at multiple time points, with careful monitoring of safety and treatment effects throughout the study period, which extends up to December 2027.

Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy