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Procedure

ESWL vs SOPIL for Pancreatic Stones

N/A
Waitlist Available
Led By Benjamin L Bick, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to compare the two techniques for breaking apart stones in the pancreatic duct: extracorporeal shock wave lithotripsy (ESWL) and single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL).

Who is the study for?
This trial is for adults with chronic pancreatitis and large pancreatic duct stones (MPDS) over 5mm, located in the head or neck of the pancreas. Candidates must have abdominal pain related to MPDS and failed previous ERCP attempts or be unsuitable for standard ERCP clearance. Exclusions include pregnancy, active alcohol use within two months, certain heart devices, prior lithotripsy attempts, and other specific medical conditions.
What is being tested?
The study compares ESWL (external shock wave therapy) with SOPIL (endoscopic shock wave therapy) for breaking up large pancreatic duct stones when standard removal has failed. The goal is to determine which method is more effective at clearing these obstructions and improving patient outcomes while also assessing cost-effectiveness.
What are the potential side effects?
Potential side effects may include discomfort from shock waves during treatment, bruising or bleeding where the waves enter the body, infection risks from endoscopy procedures like SOPIL, as well as possible complications from stone fragments passing through the digestive system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones
Procedural related adverse events
Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone
Secondary study objectives
Exocrine pancreatic insufficiency
Change in narcotic pain medication usage
Pain
+1 more
Other study objectives
Health care utilization
Mean cost of care for stone clearance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: ESWLActive Control1 Intervention
Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones
Group II: SOPILActive Control1 Intervention
Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,218,998 Total Patients Enrolled
Benjamin L Bick, MDPrincipal InvestigatorIndiana University
Jeffery J Easler, MDPrincipal InvestigatorIndiana University

Media Library

Pancreatic Stones Clinical Trial 2023: ESWL Highlights & Side Effects. Trial Name: NCT04158297 — N/A
ESWL (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04158297 — N/A
~10 spots leftby Dec 2025
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