Comparing two methods for treating pancreatic duct stones
Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones
This study is testing which of two methods works better to break apart larger pancreatic duct stones in patients who still have pain after other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT04158297 on ClinicalTrials.gov |
What this trial studies
This study compares two techniques for treating pancreatic duct stones: extracorporeal shock wave lithotripsy (ESWL) and single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL). The aim is to determine which method is more effective in breaking apart larger stones located in the pancreatic duct, which can cause significant abdominal pain and complications. Patients with stones larger than 5 mm that have not responded to standard endoscopic techniques will be included. The study will assess the outcomes of both interventions to provide clearer guidance on treatment options.
Who should consider this trial
Good fit: Ideal candidates are patients with pancreatic duct stones larger than 5 mm located in the head or neck of the pancreas who have experienced abdominal pain and have previously failed standard ERCP.
Not a fit: Patients with stones located in the body or tail of the pancreas or those with certain anatomical or health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from chronic pancreatitis and pancreatic duct stones.
How similar studies have performed: There are currently no studies directly comparing ESWL to SOPIL, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Abdominal pain related to MPDS * Previously failed ERCP performed with intent to clear MPDS, OR MPDS determined by treating physicians to not be amenable to clearance by standard ERCP techniques Exclusion Criteria: * MPDS predominantly located in the body and tail of pancreas * Any obstructing MPDS \> 5 mm located in the body and tail of pancreas * Known pancreatic head stricture precluding passage of the pancreatoscope with endoscopic stone extraction based on prior imaging or prior ERCP * Pancreatic head mass * Impacted MPDS located at the pancreatic duct orifice * Prior attempts at ESWL or SOPIL for MPDS * Walled off pancreatic necrosis * Active alcohol use, defined as any alcohol use within 2 months * Surgically altered anatomy (see text) * Gastric outlet obstruction or obstruction precluding passage of the endoscope * Standard contraindications to ERCP * Implanted cardiac pacemakers or defibrillators * Known calcified aneurysms in the path of the shockwave * Age \< 18 years, pregnancy, incarceration, unwillingness/inability to provide informed consent, or anticipated inability to follow protocol
Where this trial is running
Indianapolis, Indiana
- Indiana University Health Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Jeffery J Easler, MD — Indiana University
- Study coordinator: Gail McNulty, RN
- Email: gmcnulty@iu.edu
- Phone: 317-278-0699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.