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NCT07202559
NA

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

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

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

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)

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