drugset / Trial / NCT07202559

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.

Timeline

Start
2025-10-13
Primary completion
2027-12-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Indometacin suppository Unknown 100 mg Rectal
Background Lactated ringers solution Unknown 3 unknown Intravenous
Comparator sodium chloride Unknown 1.5 unknown Intravenous
Comparator sodium chloride Unknown 3000 ml Intravenous