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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

Must not have

Acquired pancreas divisum

Patients with prior pancreatic surgery

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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

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I am between 18 and 89 years old.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition where my pancreas is divided.

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I have had surgery on my pancreas before.

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More than one-third of my pancreatic stones are in the tail.

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I have stones in the tail or side branches of my pancreas.

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I cannot undergo general anesthesia due to heart or lung conditions.

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My blood clotting disorder cannot be corrected to a safe level.

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I have kidney stones that cannot be bypassed by a stent.

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A stent cannot be placed in my 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stone Clearance Rate

Secondary study objectives

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 / 11Eligibility criteria met