ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

Launched by INDIANA UNIVERSITY · Nov 7, 2019

Keywords

ClinConnect Summary

This clinical trial is comparing two different methods for treating large pancreatic duct stones (MPDS), which can cause serious issues like abdominal pain and digestive problems in people with chronic pancreatitis. The two techniques being studied are extracorporeal shock wave lithotripsy (ESWL), which uses shock waves from outside the body to break up stones, and single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL), a newer method that allows doctors to see the stone directly and apply shock waves to it. The goal of the trial is to find out which method works better and how well clearing these stones can improve patients' long-term health and quality of life.

To be eligible for the trial, participants must be adults aged 65 to 74 who have large pancreatic duct stones (larger than 5 mm) located in certain parts of the pancreas and have experienced abdominal pain related to these stones. They should have already undergone an attempt to remove the stones using standard methods but were unsuccessful. Participants can expect to have their condition monitored closely throughout the study to evaluate the effectiveness of each treatment method. It’s important to note that certain medical conditions and previous treatments may exclude someone from participating.

Gender

ALL

Eligibility 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