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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,250
Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL
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.
Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)
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
Incidence of post-ESWL pancreatitis
Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging.
Time frame: 24 hours
Severity of pancreatitis
Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.
Time frame: 1 month
Incidence of other post-ESWL complications
Including bleeding, infection, steinstrasse, and perforation.
Time frame: 24 hours
Incidence of fluid overload
Including pulmonary or peripheral edema and congestive heart failure.
Time frame: 24 hours
Transient adverse events related to ESWL
Transient adverse events were defined as transient injuries caused by shock waves that required no medical intervention and did not prolong hospitalisation, including asymptomatic hyperamylasaemia, haematuria, and acute gastrointestinal mucosal injury (eg, haematemesis, melena, or haem atochezia) caused by ESWL. Asymptomatic hyper amylasaemia was defined as an increase in serum amylase compared with pre ESWL levels and beyond the upper limit of the normal range but showing no related symptoms.
Time frame: 24 hours
Length of hospitalisation
Time frame: 1 month
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