Endoscopic vs. Shock-Wave Lithotripsy for Chronic Pancreatitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Prior pancreatic surgery, Pregnancy, Alcohol abuse, others

Compensation: Varies

Number of Visits: 1

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for people with chronic pancreatitis who have stubborn pancreatic duct stones causing pain and unresponsive to standard treatment. One option, Extracorporeal Shock-Wave Lithotripsy, uses shock waves outside the body to break up the stones. The other, Per-oral Pancreatoscopy-guided Lithotripsy, involves a small camera and tools inside the body to target and break the stones. The study aims to determine which method clears the stones more effectively and improves quality of life and pain. Suitable participants have chronic pancreatitis with painful stones in the main pancreatic duct that are at least 5 mm in size. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for those seeking alternatives to standard care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that per-oral pancreatoscopy-guided lithotripsy (PPL) is generally well-tolerated. A review of studies found that while some unwanted side effects can occur, they are usually not serious. Most patients undergo the treatment without major issues.

For extracorporeal shock-wave lithotripsy (ESWL), studies involving large groups of patients have shown it to be a safe option as well. Some individuals might experience mild discomfort or minor side effects like bruising, but serious problems are rare. In one study, over 90% of patients successfully completed the treatment.

Both treatments have been used before, and while side effects can occur, they are typically manageable. This makes both options reasonably safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for chronic pancreatitis because they offer innovative approaches to managing pancreatic stones. Unlike traditional methods such as surgery or endoscopic procedures, the per-oral pancreatoscopy-guided lithotripsy (PPL) uses a small camera to directly visualize and break down stones inside the pancreatic duct with electrical pulses or a laser, offering a more precise and potentially less invasive option. On the other hand, extracorporeal shock-wave lithotripsy (ESWL) uses shock waves from outside the body to target and fragment stones, allowing for a non-invasive method to treat stones without direct entry into the duct. Both treatments could provide effective alternatives that aim to reduce complications and recovery time compared to conventional approaches.

What evidence suggests that this trial's treatments could be effective for chronic pancreatitis?

This trial will compare two treatments for chronic pancreatitis: extracorporeal shock-wave lithotripsy (ESWL) and per-oral pancreatoscopy-guided lithotripsy (PPL). Research has shown that ESWL effectively breaks down stones in the pancreatic duct, with one study reporting that 73.7% of patients had all stones cleared and 70.1% experienced complete pain relief. Meanwhile, PPL aims to reduce the number of stones to relieve pain and prevent pancreatitis attacks. Both treatments have demonstrated good results in removing stones and easing pain, but their effectiveness can vary among individuals. This trial will determine which method is more effective for patients with difficult-to-remove pancreatic stones. ^{5 6 7 8 9}

Who Is on the Research Team?

Raj J Shah, MD

Principal Investigator

University of Colorado Anschutz Medical Campus, Professor of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39169663/

Long-term clinical outcomes of extracorporeal shockwave ... Complete stone clearance was achieved in 73.7% of the patients. At the end of the follow-up period, 70.1% of the patients achieved complete pain remission.

2. gi.org gi.org/journals-publications/ebgi/zhou_aug2024/

ERCP with Extracorporeal Shock-Wave Lithotripsy for ... There were multiple secondary outcomes assessed at 12- and 24-week follow-up, including change in pain score at 24 weeks, partial pain relief ( ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/apt.18224

Long‐term clinical outcomes of extracorporeal shockwave ... A total of 1929 of 2071 patients (93.1%) underwent ERCP after P-ESWL, with a technological success rate of 86.5%. Among these patients, 4.0% (78 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12049016/

The risk factors affecting effect of extracorporeal shock ... In a study involving 634 patients with chronic pancreatitis who underwent 1470 sessions of ESWL, the overall complication rate was 6.73%, with ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1590865824009629

Safety evaluation of extracorporeal shockwave lithotripsy ... The overall complication rate and TAEs rate after all P-ESWL procedures were 5.2% and 20.9%. The complications and TAEs rate decreased obviously within the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11082964/

Peroral Pancreatoscopy-Guided Lithotripsy Compared with ... Regarding long-term outcomes, the recurrence rates of pancreatic stones with POPS and ESWL were comparable at 26.6% (median observation period 176 days ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1424390322007499

Per-oral pancreatoscopy-guided lithotripsy vs. ... This study aims to compare POP-guided lithotripsy with ESWL in the management of refractory symptomatic main pancreatic duct stones.

8. turkjgastroenterol.org turkjgastroenterol.org/Content/files/sayilar/414/TJG_20240110_nlm_new_indd.pdf

Pancreatoscopy-Guided Lithotripsy for Pancreatic Duct ... We performed a systematic review and meta- analysis to evaluate the efficacy and safety of pancreatos- copy-guided lithotripsy for pancreatic ...

9. europepmc.org europepmc.org/article/med/40175795

Per-oral Pancreatoscopy-Guided Lithotripsy Versus ... Primary outcomes were technical success and clinical success of stones. Secondary outcomes were any adverse events (AEs) and the incidence of ...