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

Sponsor
Yanqing Li
Study ID
NCT06936800
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Pinaverium bromide — DRUG
    Preoperative, intraoperative, and postoperative oral administration of 100mg povidonium bromide in P-ESWL
  • Placebo for control group — DRUG
    Preoperative, intraoperative, and postoperative oral placebo 100mg for P-ESWL

Study Details

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.

Key Dates

First listed
Apr 20, 2025
Start date
Mar 1, 2025
Status verified
Apr 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Pinaverium Bromide
    Preoperative, intraoperative, and postoperative oral administration of 100mg tid of povidone bromide in p-ESWL
  • Placebo Comparator: Placebo
    Preoperative, intraoperative, and postoperative oral administration of 100mg tid of placebo in p-ESWL

Primary Outcome Measure

Incidence and grading of pancreatitis after P-ESWL (mild, moderate, and severe) [ Time Frame: 24-48 hours after pancreatic ESWL procedure ]

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