Pancreatitis, Chronic, Pancreatitis, Acute, Pancreatic Duct Stones
Conditions
Brief 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.
Interventions
DRUGIndometacin suppository
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.
DRUGNormal Saline
Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)
Sponsors
Ruijin Hospital
First Affiliated Hospital of Lanzhou University
First People's Hospital of Hangzhou
The Second Affiliated Hospital of Baotou Medical College
Shanghai Pudong New Area Gongli Hospital
Peking Union Medical College Hospital
Qilu Hospital of Shandong University
The Third Xiangya Hospital of Central South University
Affiliated Hospital of Yunnan University
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with painful chronic pancreatitis eligible for P-ESWL treatment * Ages between 18-85 years * Providing informed consent
Exclusion criteria
* 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 * Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL * Hypotension (systolic blood pressure \<90 mmHg or mean arterial pressure \<70 mmHg) * Hypo- or hypernatremia (serum Na+ levels \< 130 or \> 150 mmol/L) * Severe liver disease (cirrhosis with ascites, liver abscess) * receiving NSAIDs within 7 days * Contraindications for rectal use of NSAIDs (renal dysfunction with serum creatinine \>120 μmol/L, allergy, active gastrointestinal bleeding, ulcer disease, and NSAID use for other indications \[other than cardioprotective aspirin\]) * presence of coagulopathy or received anticoagulation therapy within 3 days * acute pancreatitis within 3 days * known active cardiovascular or cerebrovascular disease * pregnant or breastfeeding women * without a rectum (ie, status post-total proctocolectomy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-ESWL pancreatitis | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of pancreatitis | 1 month | 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 | 24 hours | Including bleeding, infection, steinstrasse, and perforation. |
| Incidence of fluid overload | 24 hours | Including pulmonary or peripheral edema and congestive heart failure. |
| Transient adverse events related to ESWL | 24 hours | 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. |
| Length of hospitalisation | 1 month | — |
Countries
China
Contacts
Primary ContactLiang-Hao Hu
Outcome results
None listed