Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP)
Launched by YANQING LI · Apr 17, 2025
Trial Information
Current as of June 27, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 carries risks: pancreatitis (4.35%), abdominal pain (42.65%), and other complications (6.73% overall).
* Pinaverium bromide relaxes the sphincter of Oddi, reduce intestinal spasms and may mitigate post-ESWL complications.
2. Objectives:
* Primary: Reduce post-p-ESWL pancreatitis incidence (per Atlanta 2012 criteria).
* Secondary: Decrease abdominal pain, other complications (bleeding...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Gender is not limited, age range is 18-85 years old (inclusive);
- • 2. 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 Criteria:
- • 1. Requiring repeat ESWL during the study period.
- • 2. Acute pancreatitis within 3 days prior to ESWL.
- • 3. Severe cardiac/pulmonary dysfunction precluding anesthesia tolerance.
- • 4. Advanced liver disease (e.g., liver failure, cirrhosis, ascites, abscess).
- • 5. Anticoagulant use within 3 days or coagulopathy.
- • 6. Suspected or confirmed pancreatic malignancy.
- • 7. Arteriosclerosis or aortic aneurysm along shockwave transmission path.
- • 8. Pregnancy or lactation.
- • 9. Known allergy to pinaverium bromide.
- • 10. Chronic pinaverium bromide use with \<3-day washout period.
- • 11. Declined participation.
About Yanqing Li
Yanqing Li is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, Yanqing Li collaborates with healthcare professionals and research institutions to design and implement rigorous clinical trials. Their expertise spans various therapeutic areas, ensuring adherence to the highest ethical standards and regulatory compliance. Through strategic partnerships and a patient-centered approach, Yanqing Li aims to contribute significantly to the development of safe and effective treatments, fostering a collaborative environment that prioritizes scientific integrity and excellence in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jinan, , China
Jinan, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported