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

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

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)

Sponsors & Collaborators

• Ruijin Hospital

  collaborator OTHER

• First Affiliated Hospital of Lanzhou University

  collaborator UNKNOWN

• First People's Hospital of Hangzhou

  collaborator OTHER

• The Second Affiliated Hospital of Baotou Medical College

  collaborator OTHER

• Shanghai Pudong New Area Gongli Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Affiliated Hospital of Yunnan University

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2027-12-01

Completion

2027-12-01

Countries

• China

Study Locations