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

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.

NCT Number	NCT07202559
Lead Sponsor	Changhai Hospital Collaborators: Ruijin Hospital, LanZhou University, First People's Hospital of Hangzhou, The Second Affiliated Hospital of Baotou Medical College, Shanghai Pudong New Area Gongli Hospital, Peking Union Medical College Hospital, Qilu Hospital of Shandong University, The Third Xiangya Hospital of Central South University, Affiliated Hospital of Yunnan University
Conditions	Pancreatitis, Chronic, Pancreatitis, Acute, Pancreatic Duct Stones
Enrollment	1,250 participants
Start Date	2025-10-13
Primary Completion	2027-12-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-13