ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

Not Applicable

Active, not recruiting

Brief 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ESWL	ESWL vs SOPIL	Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones
SOPIL	ESWL vs SOPIL	Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones

Primary Outcome Measures

Name	Time	Method
Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones	Up to 24 weeks	Combined lithotripsy and ERCP procedures
Procedural related adverse events	Up to 24 weeks	This will be described as a proportion of patients who develop post-procedure pancreatitis, bleeding, infection, perforation, organ injury, symptomatic hematoma, or Steinstrasse resulting in acute stone impaction at the papilla
Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone	Up to 24 weeks	This will be described as a proportion of patients with stone clearance. This is defined by the endoscopist's interpretation of the pancreatogram during the time of ERCP and/or subsequent imaging studies. Two blinded endoscopists will review the final pancreatogram to confirm clearance of MPDS

Secondary Outcome Measures

Name	Time	Method
Change in quality of life based on chronic pancreatitis specific instruments: PANQOLI	through study completion, an average of 1 year	Change in the pancreatitis quality of life instrument (PANQOLI) scores from baseline at 3 months, 6 months, 9 months, and 12 months. The PANQOLI score is a validated quality of life score for chronic pancreatitis with specific focus on the domains of physical function, role function, emotional function, and self-worth. The score ranges from 11 to 103, which higher scores suggesting better quality of life.
Change in exocrine insufficiency	through study completion, an average of 1 year	This will be described as a proportion of patients who experience weight gain, resolution of steatorrhea, or no longer require pancreatic enzyme supplementation after stone clearance at 3 months, 6 months, 9 months, and 12 months
Change in pain scores	through study completion, an average of 1 year	Change in Izbicki pain scores from baseline at 3 months, 6 months, 9 months, and 12 months. The Izbicki pain scale is a validated pain score for chronic pancreatitis using a visual analog scale, frequency of pain, requirement of pain medication, and pain affecting functional ability. The score ranges from 0 to 100 with higher scores suggesting more pain.
Change in narcotic pain medication usage	through study completion, an average of 1 year	Change in daily morphine milligram equivalent usage from baseline at 3 months, 6 months, 9 months, and 12 months

Locations (1): Indiana University Health Hospital
🇺🇸
Indianapolis, Indiana, United States