Pinaverium bromide: Preoperative, intraoperative, and postoperative oral administration of 100mg povidonium bromide in P-ESWL
Placebo for control group: Preoperative, intraoperative, and postoperative oral placebo 100mg for P-ESWL
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence and grading of pancreatitis after P-ESWL (mild, moderate, and severe) — 24-48 hours after pancreatic ESWL procedure The definition of postoperative pancreatitis after P-ESWL is based on the 2012 Atlanta criteria. If at least two of the following three criteria are met, the diagnosis can be made: abdominal pain consistent with pancreatitis; Within 24 hours after surgery, amylase or lipase should be at least 3 times the normal upper limit; Imaging examination shows characteristic features of pancreatitis
Trial sites (1)
Facility
City
Region
Status
Department of Gastroenterology, Qilu hospital of Shandong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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