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

NCT06936800 | Enrolling By Invitation

• 1 other identifier: QLCR20240052
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pancreatitis; Pancreatic Duct Stones

Keywords

chronic pancreatitis; pancreatic duct stones; ESWL; Pinaverium bromide; Post-ESWL pancreatitis

Outcome Measures

Primary Outcomes (1)

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

  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

  24-48 hours after pancreatic ESWL procedure

Secondary Outcomes (1)

• Incidence of abdominal painful after P-ESWL

  24-48 hours after pancreatic ESWL procedure

Other Outcomes (1)

• Incidence of other adverse events of p-ESWL

  24-48 hours after pancreatic ESWL procedure

Study Arms (2)

Pinaverium Bromide

EXPERIMENTAL

Preoperative, intraoperative, and postoperative oral administration of 100mg tid of povidone bromide in p-ESWL

Drug: Pinaverium bromide

Placebo

PLACEBO COMPARATOR

Preoperative, intraoperative, and postoperative oral administration of 100mg tid of placebo in p-ESWL

Drug: Placebo for control group

Interventions

Pinaverium bromide DRUG

Preoperative, intraoperative, and postoperative oral administration of 100mg povidonium bromide in P-ESWL

Pinaverium Bromide

Placebo for control group DRUG

Preoperative, intraoperative, and postoperative oral placebo 100mg for P-ESWL

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Known allergy to pinaverium bromide.
• Chronic pinaverium bromide use with \<3-day washout period.
• Declined participation.

Sponsors & Collaborators

• Yanqing Li: lead

Study Sites (1)

Department of Gastroenterology, Qilu hospital of Shandong University

Jinan, Wenhuaxi Road, 107, China

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

pinaverium; Control Groups

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Gastroenterology, Qilu hospital of Shandong University

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 20, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)