By InvitationNot Applicable

Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP)

China288 participantsStarted 2025-03-01

Plain-language 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 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Incidence and grading of pancreatitis after P-ESWL (mild, moderate, and severe)

Timeframe: 24-48 hours after pancreatic ESWL procedure

Trial details

NCT IDNCT06936800

SponsorYanqing Li

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

View on ClinicalTrials.gov More Chronic Pancreatitis trials