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

60 Participants Needed

Trial Summary

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 ESWL for pancreatic stones?

Research shows that extracorporeal shock wave lithotripsy (ESWL) is effective in breaking down pancreatic stones, as evidenced by multiple studies evaluating its success in stone clearance and long-term outcomes. ^{1 2 3 4 5}

Is ESWL or SOPIL generally safe for treating pancreatic stones?

The safety of ESWL (Extracorporeal Shock Wave Lithotripsy) and SOPIL (a specific procedure for pancreatic stones) can be inferred from related procedures. For example, endoscopic procedures for pancreatic issues have shown some risks like pancreatitis (inflammation of the pancreas) and bleeding, but these are generally considered manageable. Overall, these procedures are seen as having acceptable safety profiles in medical practice. ^{6 7 8 9 10}

How does the treatment ESWL vs SOPIL for pancreatic stones differ from other treatments?

ESWL (extracorporeal shock wave lithotripsy) is a well-established treatment that uses shock waves to break down pancreatic stones, while SOPIL (single-operator pancreatoscopy with intraductal lithotripsy) is a newer technique that involves directly visualizing and fragmenting stones within the pancreatic duct. SOPIL offers a more direct approach compared to ESWL, which is non-invasive and performed externally. ^{1 2 11 12 13}

What is the purpose of this trial?

Pancreatic duct stones can cause obstruction of the main pancreatic duct leading to abdominal pain, exocrine pancreatic insufficiency, and recurrent acute pancreatitis. By removing pancreatic duct stones, the obstruction can be relieved, and this can improve symptoms. Small stones can be removed with standard endoscopic retrograde cholangiopancreatography (ERCP) and stone removal, but larger stones may require lithotripsy to break up the stone before removal. The two current methods of lithotripsy include extracorporeal shock wave lithotripsy (ESWL) and single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL). ESWL is based on concentrating shock wave energy to the stone through an external device. SOPIL is a newer technique based on direct visualization of the stone during ERCP and targeting the stone with a shock wave catheter. There are currently no studies directly comparing ESWL to SOPIL for breaking apart stones in the pancreatic duct, so this study is designed to compare the two techniques. Objective #1: Obtain pilot data to determine the optimal method of clearing large MPDS Objective #2: Obtain pilot data to assess how effective large MPDS clearance is in improving long term patient centered outcomes Objective #3: Obtain pilot data to measure the cost effectiveness of large MPDS clearance

Research Team

Jeffery J Easler, MD

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Treatment of pancreatic stones with extracorporeal shock wave lithotripsy: results of a multicenter survey. [2005]

2. Germany pubmed.ncbi.nlm.nih.gov

A comparative study between single-operator pancreatoscopy with intraductal lithotripsy and extracorporeal shock wave lithotripsy for the management of large main pancreatic duct stones. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Quantitative factors of unenhanced CT for predicting fragmenting efficacy of extracorporeal shock wave lithotripsy on pancreatic duct stones. [2020]

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

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

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

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

6. Italy pubmed.ncbi.nlm.nih.gov

Preventing post-ERCP pancreatitis: where are we? [2007]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Complications after endoscopic interventions on the major duodenal papilla]. [2006]

8. Germany pubmed.ncbi.nlm.nih.gov

Somatostatin for prevention of post-ERCP pancreatitis: a randomized, double-blind trial. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Endoscopic papillectomy for neoplastic ampullary lesions: A systematic review with pooled analysis. [2021]

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

Efficacy and safety of endoscopic ultrasound-guided pancreatic duct drainage (EUS-PDD): A systematic review and meta-analysis of 714 patients. [2020]

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

Extracorporeal shock-wave lithotripsy of pancreatic calculi. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[ESWL-therapy of pancreatic duct calculi]. [2006]

13. Japan pubmed.ncbi.nlm.nih.gov

[The studies of extracorporeal shock wave lithotripsy (ESWL) for pancreatic ductal stones]. [2020]