Status:
ENROLLING_BY_INVITATION
Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP)
Lead Sponsor:
Yanqing Li
Conditions:
Chronic Pancreatitis
Pancreatic Duct Stones
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study aims to evaluate whether perioperative pinaverium bromide (a calcium antagonist) reduces post-ESWL complications (pancreatitis, abdominal pain, infection) in chronic pancreatitis patients w...
Detailed Description
1. Background: * Chronic pancreatitis (CP) has a global incidence of 9.62/100,000, often complicated by pancreatic duct stones (90% of CP patients). * p-ESWL is first-line for stones \>5 mm but...
Eligibility Criteria
Inclusion
- Gender is not limited, age range is 18-85 years old (inclusive);
- Perform P-ESWL treatment for painful chronic pancreatitis with positive pancreatic duct stones ≥ 5mm, mainly located in the head or body of the pancreas.
Exclusion
- Requiring repeat ESWL during the study period.
- Acute pancreatitis within 3 days prior to ESWL.
- Severe cardiac/pulmonary dysfunction precluding anesthesia tolerance.
- Advanced liver disease (e.g., liver failure, cirrhosis, ascites, abscess).
- Anticoagulant use within 3 days or coagulopathy.
- Suspected or confirmed pancreatic malignancy.
- Arteriosclerosis or aortic aneurysm along shockwave transmission path.
- Pregnancy or lactation.
- Known allergy to pinaverium bromide.
- Chronic pinaverium bromide use with \<3-day washout period.
- Declined participation.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT06936800
Start Date
March 1 2025
End Date
December 30 2027
Last Update
April 20 2025
Active Locations (1)
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1
Department of Gastroenterology, Qilu hospital of Shandong University
Jinan, Wenhuaxi Road, China, 107