ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
Pancreatitis, Chronic
About this trial
This is an interventional treatment trial for Pancreatitis, Chronic focused on measuring pancreatic duct stone, extracorporeal shock-wave lithotripsy, pancreatoscopy, quality of life, chronic pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Subjects with abdominal pain secondary to chronic calcific pancreatitis and main pancreatic duct stones found on cross-sectional imaging, EUS, or ERP.
- Subjects aged 18-80.
- Subjects must have failed at least one prior attempt of standard ERP to remove the PD stones.
- Main PD stones in the head or body that are greater than 50% of the immediate downstream diameter of the pancreatic duct.
- Stones ≥5 mm in diameter or impacted in the main PD on cross-sectional imaging or EUS. If multiple locations of stones are noted within the main PD, pancreatic tail stones cannot comprise more than one-third of the stone burden within the main PD.
Exclusion Criteria:
- Subjects who have previously received PPL or ESWL.
- Patients with PD stones isolated in the tail or side branches of the main duct.
- Inability to place a transpapillary pancreatic duct stent at index ERP.
- Patients with prior pancreatic surgery
- Pancreas divisum or acquired pancreas divisum requiring minor papilla cannulation
- Pregnancy
- Significant cardiopulmonary co-morbidities precluding general anesthesia
- Patients with implanted cardiac pacemakers or defibrillators
- Patients with coagulation disorders that cannot be corrected to an INR below 2.0
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Extracorporeal Shock-Wave Lithotripsy
Per-oral Pancreatoscopy-guided Lithotripsy
Stone localization will first be performed by obtaining high-quality plain films of the pancreatic area in left and right oblique positions using a two-dimensional radiologic targeting system.Depending on the stone localization, ESWL will then be performed with the patient in either slight left or right lateral decubitus with shock waves entering the body from the ventral side. The shockwaves will be focused first on the most distally located stone within the main duct and then on other calculi moving from the head towards the body. If a stent has been inserted during preceding ERP then this may also serve as a guide to target main pancreatic duct stones by ESWL. A total of one hour of ESWL at a rate of 60-120 shocks/minute will be delivered in one treatment session.
Standard ERP will be performed to cannulate the PD, perform pancreatic sphincterotomy, and stricture dilation as necessary. A pancreatoscope (Spyglass Digital System, Boston Scientific, Marlborough, MA) will then be inserted through the duodenoscope into the PD. For PPL, electrical pulses will be delivered through an aqueous medium by EHL or LL with the probe tip in contact with or 1-2mm away from the stone. Settings for EHL (1.9F fiber; Autolith, Northgate Technologies, Elgin, IL) are 10-20 pulses/second with a power of 50-100; and for LL (200, 272, or 365 micrometer fiber, Versa Pulse Power Suite 20-W Holmium laser, New Star, Roseville, CA) ranging from 0.8 - 2.5 Joules with a frequency of 8-15Hz and power of 9-30 W. A maximum of 1 hour of intraductal lithotripsy will be allowed to reduce performance bias.