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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWL | Active Comparator | Extracorporeal shock wave lithotripsy for the treatment of pancreatic duct stones |
|
| SOPIL | Active Comparator | Single Operator Pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESWL vs SOPIL | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 24 weeks |
| Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones | Combined lithotripsy and ERCP procedures | Up to 24 weeks |
| 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 | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Mean cost of care for stone clearance | Costs will be estimated by procedural fees including the cost of ESWL, lithotripsy, ERCP, anesthesia, and fluoroscopy. | up to 24 weeks |
| Health care utilization | Change in frequency of emergency room visits or hospitalization after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery J Easler, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| 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. | through study completion, an average of 1 year |
| 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 | through study completion, an average of 1 year |
| 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 | through study completion, an average of 1 year |
| through study completion, an average of 1 year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |