← Back to Search

Endoscopic vs. Shock-Wave Lithotripsy for Chronic Pancreatitis

N/A

Waitlist Available

Led By Raj J Shah, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects aged 18-89

Subjects with abdominal pain secondary to chronic calcific pancreatitis and main pancreatic duct stones found on cross-sectional imaging, EUS, or ERP with upstream PD dilation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up

Awards & highlights

Study Summary

This trial will compare two different ways to treat patients with chronic pancreatitis who have stones that can't be removed with a regular endoscopy.

Who is the study for?

Adults aged 18-89 with chronic calcific pancreatitis and main pancreatic duct stones causing pain, who haven't responded to initial endoscopic therapy. Eligible participants have stones at least 5mm wide or impacted in the main duct, located in the head or body of the pancreas. Those with certain conditions like nontraversable ansa loop, prior pancreatic surgery, significant health issues preventing anesthesia, coagulation disorders not correctable to an INR below 2.0, pregnancy, acquired pancreas divisum or recent PPL/ESWL treatment are excluded.Check my eligibility

What is being tested?

The trial compares two treatments for removing painful stones from the pancreatic duct: Extracorporeal Shock-Wave Lithotripsy (ESWL) and Per-oral Pancreatoscopy-guided Lithotripsy (PPL). It's a randomized controlled study focusing on how well these treatments clear out stones and improve patients' quality of life and pain levels after failing initial endoscopic therapy.See study design

What are the potential side effects?

Potential side effects may include abdominal discomfort or pain due to procedure-related complications such as inflammation or infection; there might also be risks associated with sedation required for these procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 89 years old.

Select...

I have chronic pancreatitis with pain, duct stones, and duct dilation.

Select...

I have large stones in my pancreas that are more than half the size of the nearby pancreatic duct.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Stone Clearance Rate

Secondary outcome measures

Change In Quality of Life as Measured Using PANQOLI Score

Change in Pain Levels as Measured Using the COMPAT Score

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Per-oral Pancreatoscopy-guided LithotripsyActive Control1 Intervention

Standard ERP will be performed to cannulate the PD, perform pancreatic sphincterotomy, and stricture dilation as necessary. A pancreatoscope (Spyglass Digital System, Boston Scientific, Marlborough, MA) will then be inserted through the duodenoscope into the PD. For PPL, electrical pulses will be delivered through an aqueous medium by EHL or LL with the probe tip in contact with or 1-2mm away from the stone. Settings for EHL (1.9F fiber; Autolith, Northgate Technologies, Elgin, IL) are 10-20 pulses/second with a power of 50-100; and for LL (200, 272, or 365 micrometer fiber, Versa Pulse Power Suite 20-W Holmium laser, New Star, Roseville, CA) ranging from 0.8 - 2.5 Joules with a frequency of 8-15Hz and power of 9-30 W. A maximum of 1 hour of intraductal lithotripsy will be allowed to reduce performance bias.

Group II: Extracorporeal Shock-Wave LithotripsyPlacebo Group1 Intervention

Stone localization will first be performed by obtaining high-quality plain films of the pancreatic area in left and right oblique positions using a two-dimensional radiologic targeting system.Depending on the stone localization, ESWL will then be performed with the patient in either slight left or right lateral decubitus with shock waves entering the body from the ventral side. The shockwaves will be focused first on the most distally located stone within the main duct and then on other calculi moving from the head towards the body. If a stent has been inserted during preceding ERP then this may also serve as a guide to target main pancreatic duct stones by ESWL. A total of one hour of ESWL at a rate of 60-120 shocks/minute will be delivered in one treatment session.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,433 Total Patients Enrolled

Raj J Shah, MDPrincipal InvestigatorUniversity of Colorado Anschutz Medical Campus, Professor of Medicine

2 Previous Clinical Trials

797 Total Patients Enrolled

Media Library

Extracorporeal Shock-Wave Lithotripsy Clinical Trial Eligibility Overview. Trial Name: NCT04115826 — N/A

Chronic Pancreatitis Research Study Groups: Per-oral Pancreatoscopy-guided Lithotripsy, Extracorporeal Shock-Wave Lithotripsy

Chronic Pancreatitis Clinical Trial 2023: Extracorporeal Shock-Wave Lithotripsy Highlights & Side Effects. Trial Name: NCT04115826 — N/A

Extracorporeal Shock-Wave Lithotripsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04115826 — N/A

Frequently Asked Questions

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

Does this research include geriatric participants?

"This medical study is inviting participants that are aged above 18 and below 80 for participation."

Answered by AI

How can I become a participant in this scientific experiment?

"To be eligible for this clinical trial, patients must have a diagnosis of chronic pancreatitis and should fall between the ages of 18-80. Moreover, it is required that participants had previously tried to remove PD stones using standard ERP without success."

Answered by AI

Does this research project still accept new participants?

"The clinical trial mentioned is no longer enrolling patients, as per the information posted on clinicaltrials.gov. Initially listed on January 2nd 2020 and last updated April 29th 2021, this research project has concluded its recruitment phase; however, there are 82 other trials that require participants at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis

2020. "ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04115826.

All > Chronic Pancreatitis