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

  • STATUS
    Recruiting
  • End date
    Nov 10, 2023
  • participants needed
    60
  • sponsor
    Indiana University
Updated on 10 May 2022
endoscopic ultrasound
abdominal pain
endoscopic retrograde cholangiopancreatography
acute pancreatitis
pancreatic insufficiency
acute recurrent pancreatitis
lithotripsy

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

Details
Condition Chronic Pancreatitis, Pancreatic Duct Stone
Treatment ESWL vs SOPIL
Clinical Study IdentifierNCT04158297
SponsorIndiana University
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
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