NCT07202559

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatitis, Chronic
• Pancreatitis, Acute
• Pancreatic Duct Stones

Interventions

Type	Name	Description
DRUG	Indometacin suppository	Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL
DRUG	Lactated ringers solution	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.
DRUG	Normal Saline	Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-10-02
• Last updated: 2026-04-13

Locations

10 sites across 1 country: China