Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy
Aggressive Intravenous Hydration With Lactated Ringer's Solution Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy: A Multicentre, Superiority, Randomised, Controlled Trial
Changhai Hospital
1,250 participants
Oct 13, 2025
INTERVENTIONAL
Conditions
Summary
This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone. The study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin. The trial will be conducted at multiple centers, ensuring a broad and diverse patient population. The primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure. This study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.
Eligibility
Plain Language Summary
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Interventions
Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL
Intravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h.
Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)
Locations(10)
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NCT07202559