Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP)
Enrolling by invitationNot applicableNCT06936800
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study aims to evaluate whether perioperative pinaverium bromide (a calcium antagonist) reduces post-ESWL complications (pancreatitis, abdominal pain, infection) in chronic pancreatitis patients with pancreatic duct stones ≥5mm. A single-center, randomized, double-blind, placebo-controlled design will be used, with 288 participants allocated to either pinaverium bromide (100mg tid) or placebo before and after p-ESWL.
Study details
- Official title
- Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP): a Single-center, Double-blind, Randomized, Placebo-controlled Trial.
- Conditions
- Chronic Pancreatitis
- Pancreatic Duct Stones
- Interventions
- Drug: Pinaverium bromide
- Drug: Placebo for control group
- Sponsor
- Yanqing Li
- Organization
- Shandong University
- Start date
- 2025-03-01
- Primary completion
- 2027-12-30
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06936800