RecruitingNot ApplicableNCT07202559

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


Sponsor

Changhai Hospital

Enrollment

1,250 participants

Start Date

Oct 13, 2025

Study Type

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Indometacin suppository, a drug called Lactated ringers solution, and others for people with pancreatic duct stones, pancreatitis, acute, and other related conditions. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIndometacin suppository

Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL

DRUGLactated 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.

DRUGNormal 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

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NCT07202559


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