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.
Patients with painful chronic pancreatitis eligible for P-ESWL treatment
Ages between 18-85 years
Providing informed consent
Patients readmitted to the hospital for ESWL during the study period
contraindications to ESWL
Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients ≥ 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP>100pg/ml or Ejection Fraction value<50% should be excluded
Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients ≥ 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) <70% are excluded
Parallel
Indometacin suppository
DrugAdministration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL
Lactated ringers solution
DrugIntravenous 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.
Normal Saline
DrugIntravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)
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.
Severity of pancreatitis
Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.
Incidence of other post-ESWL complications
Including bleeding, infection, steinstrasse, and perforation.
Incidence of fluid overload
Including pulmonary or peripheral edema and congestive heart failure.
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.
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Changhai Hospital
Lead sponsor
Ruijin Hospital
Collaborator
LanZhou University
Collaborator
First People's Hospital of Hangzhou
Collaborator
The Second Affiliated Hospital of Baotou Medical College
Collaborator
Shanghai Pudong New Area Gongli Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Affiliated Hospital of Yunnan University
Collaborator
