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Aggressive Intravenous Hydration With or Without Indometacin to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy
Sponsor: Changhai Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
1250
Start Date
2025-12-01
Completion Date
2027-12-01
Last Updated
2025-10-02
Healthy Volunteers
No
Interventions
Indometacin suppository
Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL
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.
Normal Saline
Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)
Locations (10)
The Second Affiliated Hospital of Baotou Medical College
Baotou, China
Peking Union Medical College Hospital
Beijing, China
Hangzhou First People's Hospital
Hangzhou, China
The Third Xiangya Hospital of Central South University
Hunan, China
The First Hospital of Lanzhou University
Lanzhou, China
Qilu Hospital of Shandong University
Shandong, China
Changhai Hospital
Shanghai, China
Ruijin Hospital
Shanghai, China
Shanghai Pudong New Area Gongli Hospital
Shanghai, China
Yunnan University Affiliated Hospital
Yunnan, China