ESWL vs SOPIL for Pancreatic Stones

Overseen By Gail McNulty, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Pancreatic head mass, Active alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for breaking up large stones in the pancreatic duct, which can cause severe abdominal pain and other complications. One method uses shock waves from outside the body (ESWL), while the other directly targets the stone with a small camera and shock wave device during a procedure (SOPIL). The goal is to determine which method more effectively clears these stones and improves symptoms. The trial seeks participants with large stones in specific parts of their pancreas, who experience abdominal pain from these stones, and who have not found success with standard treatments. As an unphased trial, this study offers an opportunity to explore innovative treatments that could enhance quality of life.

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 prior data suggests that these techniques are safe for treating pancreatic duct stones?

Research has shown that both ESWL and SOPIL are generally safe methods for breaking up large pancreatic stones. Studies have found that ESWL, which uses shock waves from outside the body to target the stones, has a low complication rate of 5.2% after multiple treatments, indicating that serious side effects are rare. Additionally, ESWL is usually well-tolerated, even with repeated sessions.

For SOPIL, which involves using a scope to directly see and break up the stones, the safety record is also favorable. A review of studies reported side effects in about 12% of cases, meaning most patients experience few problems. Both treatments are considered effective and promising options for patients with pancreatic duct stones. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for pancreatic duct stones because they offer innovative approaches compared to traditional options, like endoscopic retrograde cholangiopancreatography (ERCP) with stone extraction and surgery. Extracorporeal Shock Wave Lithotripsy (ESWL) uses shock waves to break down stones from outside the body, potentially reducing the need for more invasive procedures. On the other hand, Single Operator Pancreatoscopy and Intraductal Lithotripsy (SOPIL) allows for direct visualization and targeted treatment of stones within the pancreatic duct, offering precision that traditional methods might lack. Both treatments aim to improve patient outcomes with less invasiveness and quicker recovery times.

What evidence suggests that this trial's treatments could be effective for pancreatic duct stones?

This trial will compare ESWL and SOPIL for treating pancreatic duct stones. Research has shown that both ESWL and SOPIL effectively break up stones in the pancreatic duct. For ESWL, studies indicate that 73.7% to 76% of patients achieve complete stone removal, with many experiencing long-term pain relief. Specifically, one study found that 82.6% of patients reported pain relief six months after the procedure. SOPIL, which allows doctors direct visualization during the procedure, also boasts high success rates and is considered a promising alternative to ESWL. Both treatments are safe and effective, offering good options for treating large pancreatic stones. ^{3 6 7 8 9}

Who Is on the Research Team?

Jeffery J Easler, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

MPDS located in the head, neck, or neck/body junction of the pancreas

MPDS > 5 mm in size

Abdominal CT scan, Endoscopic ultrasound, or prior ERCP demonstrating MPDS

Exclusion Criteria

Pregnancy

MPDS predominantly located in the body and tail of pancreas

Any obstructing MPDS > 5 mm located in the body and tail of pancreas

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either extracorporeal shock wave lithotripsy (ESWL) or single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL) for the treatment of pancreatic duct stones

Up to 24 weeks

Follow-up

Participants are monitored for changes in quality of life, pain scores, and narcotic pain medication usage

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ESWL
• SOPIL

Trial Overview 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.

How Is the Trial Designed?

Group I: ESWL Active Control 1 Intervention

Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones

Group II: SOPIL Active Control 1 Intervention

Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

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. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-03801-6

The risk factors affecting effect of extracorporeal shock wave ... This study aimed to investigate the factors affecting effect of extracorporeal shock wave lithotripsy (ESWL) for pancreatic duct stones.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3218149/

Extracorporeal shock wave lithotripsy for pancreatic and ... In 76% of patients, the PD cleared completely, in 17% partially, and there was clearance failure in the remaining 7%[7] (Table 1 and Figures 4 and 5). Similar ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1424390319306829

ESWL for large pancreatic calculi: Report of over 5000 ... Of the 4280 patients followed up for 6 months, 3529 (82.6%) patients were pain free. Another 512 (11.9%) patients had significant reduction in VAS score. In 229 ...

5. cghjournal.org cghjournal.org/article/S1542-3565(05)00530-6/pdf

Long-term Results of Extracorporeal Shockwave Lithotripsy ... Conclusions: ESWL and endoscopic treat- ment of pancreatic stones proved to be effective for long-term pain relief, especially in patients in whom stones were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10585860/

Adverse events of pancreatic extracorporeal shock wave ... verified that P-ESWL is a safe means in patients with coexisting pancreatic stones and pancreatic pseudocysts, but pancreatic portal ...

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

Safety evaluation of extracorporeal shockwave lithotripsy ... P-ESWL is a safe treatment for pancreatic stones. Multiple P-ESWL sessions did not increase the complications and TAEs rate.

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

Long‐term clinical outcomes of extracorporeal shockwave ... Long-term efficacy was evaluated in approximately 80.3% (1664/2071) of patients with complete follow-up data. The abdominal pain patterns ...

9. dldjournalonline.com dldjournalonline.com/article/S1590-8658(24)00962-9/abstract

Experience based on a large chronic pancreatitis cohort Totally 2,071 patients underwent 5,002 sessions of P-ESWL were included. The overall complication rate and TAEs rate after all P-ESWL procedures were 5.2% and ...