Clinical trial NCT04158297: ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones
Official title: Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pancreatitis
Pancreatic Duct Stone
Keywords: Extracorporeal shock wave lithotripsy
Intraductal lithotripsy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone
timeFrame: Up to 24 weeks
measure: Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones
timeFrame: Up to 24 weeks
measure: Procedural related adverse events
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change in pain scores
timeFrame: through study completion, an average of 1 year
measure: Change in quality of life based on chronic pancreatitis specific instruments: PANQOLI
timeFrame: through study completion, an average of 1 year
measure: Change in narcotic pain medication usage
timeFrame: through study completion, an average of 1 year
measure: Change in exocrine insufficiency
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Mean cost of care for stone clearance
timeFrame: up to 24 weeks
measure: Health care utilization
timeFrame: through study completion, an average of 1 year
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Jeffery J Easler, MD
role: PRINCIPAL_INVESTIGATOR
References: