Back to resultsESWL Versus SOPIL for Treatment of Pancreatic Duct Stones
Primary Purpose
Chronic Pancreatitis, Pancreatic Duct Stone
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ESWL vs SOPIL
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Extracorporeal shock wave lithotripsy, Intraductal lithotripsy
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
Sites / Locations
- Indiana University Health Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ESWL
SOPIL
Arm Description
Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones
Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones
Outcomes
Primary Outcome Measures
Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone
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
Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones
Combined lithotripsy and ERCP procedures
Procedural related adverse events
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
Secondary Outcome Measures
Change in pain scores
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 quality of life based on chronic pancreatitis specific instruments: PANQOLI
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 narcotic pain medication usage
Change in daily morphine milligram equivalent usage from baseline at 3 months, 6 months, 9 months, and 12 months
Change in exocrine insufficiency
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04158297
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Pancreatic Duct Stone
Keywords
Extracorporeal shock wave lithotripsy, Intraductal lithotripsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESWL
Arm Type
Active Comparator
Arm Description
Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones
Arm Title
SOPIL
Arm Type
Active Comparator
Arm Description
Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones
Intervention Type
Procedure
Intervention Name(s)
ESWL vs SOPIL
Intervention Description
To compare the efficacy of single operator pancreatoscopy (SOP) with intracorporeal lithotripsy (SOPIL) to extracorporeal shock wave lithotripsy (ESWL) for the treatment of main pancreatic duct stones (MPDS) in patients with chronic pancreatitis.
Primary Outcome Measure Information:
Title
Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone
Description
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
Time Frame
Up to 24 weeks
Title
Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones
Description
Combined lithotripsy and ERCP procedures
Time Frame
Up to 24 weeks
Title
Procedural related adverse events
Description
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
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Change in pain scores
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Change in quality of life based on chronic pancreatitis specific instruments: PANQOLI
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Change in narcotic pain medication usage
Description
Change in daily morphine milligram equivalent usage from baseline at 3 months, 6 months, 9 months, and 12 months
Time Frame
through study completion, an average of 1 year
Title
Change in exocrine insufficiency
Description
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
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Mean cost of care for stone clearance
Description
Costs will be estimated by procedural fees including the cost of ESWL, lithotripsy, ERCP, anesthesia, and fluoroscopy.
Time Frame
up to 24 weeks
Title
Health care utilization
Description
Change in frequency of emergency room visits or hospitalization after treatment
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery J Easler, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones
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