Endoscopic vs. Shock-Wave Lithotripsy for Chronic Pancreatitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Compensation: Varies

Number of Visits: 1

Duration: Up to 4 hours (four 1-hour sessions)

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-center randomized controlled trial comparing extracorporeal shock-wave lithotripsy (ESWL) with per-oral pancreatoscopy-guided lithotripsy (PPL) in the treatment of patients with chronic pancreatitis and refractory main pancreatic duct stones. This study will be comparing the two treatment options for patients who have stones that fail initial endoscopic therapy via endoscopic retrograde pancreatography (ERCP). The study will look at the stone clearance rates and patient-centered outcomes including quality of life and pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for chronic pancreatitis?

Research shows that both extracorporeal shock wave lithotripsy (ESWL) and per-oral pancreatoscopy-guided lithotripsy are effective in managing pancreatic duct stones in chronic pancreatitis, with ESWL being a standard treatment and POP emerging as a useful method. Studies indicate that these treatments can provide significant pain relief and improve ductal stone clearance. ^{1 2 3 4 5}

Is extracorporeal shock-wave lithotripsy safe for humans?

Extracorporeal shock-wave lithotripsy (ESWL) is generally considered safe, but it can cause some side effects, mainly due to the scattering of shock waves. These side effects can vary and are sometimes hard to predict, but they are usually manageable. ^{2 6 7 8 9}

How does the treatment for chronic pancreatitis using endoscopic and shock-wave lithotripsy differ from other treatments?

This treatment is unique because it combines extracorporeal shock-wave lithotripsy (ESWL), which uses sound waves to break up stones from outside the body, with endoscopic techniques that allow direct access to the pancreatic duct to remove or break up stones. This approach is less invasive than surgery and can provide long-term pain relief for patients with chronic pancreatitis. ^{1 3 4 10 11}

Research Team

Raj J Shah, MD

Principal Investigator

University of Colorado Anschutz Medical Campus, Professor of Medicine

Eligibility Criteria

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.

Inclusion Criteria

Stones ≥ 5 mm in diameter or impacted in the main PD on cross-sectional imaging or EUS

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

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

Exclusion Criteria

I have a condition where my pancreas is divided.

Patients with ongoing alcohol and/or illicit drug use

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either per-oral pancreatoscopy-guided lithotripsy or extracorporeal shock-wave lithotripsy for stone clearance

Up to 4 hours (four 1-hour sessions)

Follow-up

Participants are monitored for changes in quality of life and pain levels at multiple intervals

12 months

Follow-up assessments at 1, 3, 6, and 12 months

Treatment Details

Interventions

• Extracorporeal Shock-Wave Lithotripsy
• Per-oral Pancreatoscopy-guided Lithotripsy

Trial Overview 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.

Participant Groups

Group I: Per-oral Pancreatoscopy-guided Lithotripsy Active Control 1 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 Lithotripsy Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Per-oral pancreatoscopy-guided lithotripsy vs. extracorporeal shock wave lithotripsy for treating refractory main pancreatic duct stones in chronic pancreatitis: Protocol for an open-label multi-center randomized clinical trial. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Per-oral pancreatoscopy-guided lithotripsy for the endoscopic management of pancreatolithiasis: A systematic review and meta-analysis. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

Endoscopic treatment for chronic pancreatitis: indications, technique, results. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Long-term results of combined ESWL and ERCP treatment of chronic calcific pancreatitis. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term results of extracorporeal shockwave lithotripsy and endoscopic therapy for pancreatic stones. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events of pancreatic extracorporeal shock wave lithotripsy: a literature review. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

Post-ESWL and post-ERCP pancreatitis in patients with chronic pancreatitis: Do they share the same risks? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Washington University experience with extracorporeal shock-wave lithotripsy of pancreatic duct calculi. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Extracorporeal Shock Wave Lithotripsy for Chronic Pancreatitis Patients With Stones After Pancreatic Surgery. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Risk factors for complications of pancreatic extracorporeal shock wave lithotripsy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Extracorporeal shock wave lithotripsy with a transportable mini-lithotripter and subsequent endoscopic treatment improves clinical outcome in obstructive calcific chronic pancreatitis. [2011]