Status:
NOT_YET_RECRUITING
Aggressive Intravenous Hydration With or Without Indometacin to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Ruijin Hospital
First Affiliated Hospital of Lanzhou University
Conditions:
Pancreatitis, Chronic
Pancreatitis, Acute
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Patients with painful chronic pancreatitis eligible for P-ESWL treatment
- Ages between 18-85 years
- Providing informed consent
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT07202559
Start Date
December 1 2025
End Date
December 1 2027
Last Update
October 2 2025
Active Locations (10)
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1
The Second Affiliated Hospital of Baotou Medical College
Baotou, China
2
Peking Union Medical College Hospital
Beijing, China
3
Hangzhou First People's Hospital
Hangzhou, China
4
The Third Xiangya Hospital of Central South University
Hunan, China