Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones
Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones
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
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