ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones (NCT04158297) | Clinical Trial Compass
CompletedNot Applicable
ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones
United States30 participantsStarted 2019-11-13
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone
Timeframe: Up to 24 weeks
2
Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones