ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

Indiana University

Status: Active, not recruiting

Conditions: Chronic Pancreatitis; Pancreatic Duct Stone

Treatments: Procedure: ESWL vs SOPIL

Study type: Interventional

Funder types: Other

Identifiers

NCT04158297

1909140534

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

ESWL

Active Comparator group

Description:

Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones

Treatment:

Procedure: ESWL vs SOPIL

SOPIL

Active Comparator group

Description:

Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones

Treatment:

Procedure: ESWL vs SOPIL