ClinConnect ClinConnect Logo
Search / Trial NCT06936800

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

Chronic Pancreatitis Pancreatic Duct Stones Eswl Pinaverium Bromide Post Eswl Pancreatitis

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.

Locations

Jinan, , China

Jinan, , China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported