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Procedure

ESWL 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Exocrine pancreatic insufficiency

Change in narcotic pain medication usage

Pain

+1 more

Other outcome measures

Health care utilization

Mean cost of care for stone clearance

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,922 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there remaining opportunities for patients to join this research endeavor?

"The clinical trial is in full effect, as noted on the official website. The study was initially launched on November 13th 2019 and has undergone recent updates from November 28th 2022."

Answered by AI

What are the most ambitious goals of this medical experiment?

"This 24-week clinical trial seeks to measure the mean number of lithotripsy and ERCP procedures needed for stone clearance. Secondary objectives include assessing changes in pain scores (measured with Izbicki's validated VAS scale, which ranges from 0 to 100), exocrine insufficiency (weight gain or resolution of steatorrhea) and narcotic medication usage over a 3 month to 12 month period."

Answered by AI

How many volunteers are enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial was advertised on November 13th 2019 and has since been updated on November 28th 2022. 60 participants from a single location are being sought after for this experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

Jeffrey Easler 2019. "ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04158297.

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