ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
This is a multi-center randomized controlled trial comparing extracorporeal shock-wave
 lithotripsy (ESWL) with per-oral pancreatoscopy-guided lithotripsy (PPL) in the treatment of
 patients with chronic pancreatitis and refractory main pancreatic duct stones. This study
 will be comparing the two treatment options for patients who have stones that fail initial
 endoscopic therapy via endoscopic retrograde pancreatography (ERCP). The study will look at
 the stone clearance rates and patient-centered outcomes including quality of life and pain.
Patients with chronic pancreatitis frequently develop obstructing pancreatic duct stones
 which can lead to severe pain. Current standard methods to remove these stones include ERCP
 and extracorporeal shock-wave lithotripsy (ESWL) which are limited in removing larger and
 multiple impacted stones. Availability in the USA of ESWL for this indication also may be
 limited even at major referral centers. The introduction of single-operator per-oral
 pancreatoscopy (SpyGlassTM) has enabled direct intraductal visualization to target stones.
 Retrospective studies demonstrate a high success rate but literature is quite limited,
 uncontrolled, and highly selective. Further, many experts and recent European Society
 Guidelines suggest that ESWL is the only primary therapy for larger stones (5mm or larger)
 and that intraductal endoscopy and lithotripsy should only be used for 'salvage' therapy in
 select patients.

 A critical need exists to compare the efficacy of per oral pancreatoscopy-guided lithotripsy
 (PPL) with ESWL to determine which therapy is most efficacious in removing refractory PD
 stones. The investigators believe ERCP with POP has distinct advantages of localizing
 'shocks' to the stones, helping to identify and treat underlying strictures in the duct, and
 lithotripsy of multiple stones can be performed at a single session with a recent
 multi-center international retrospective study showing all stones removed in a single session
 in over 70% of cases. Therefore, this project seeks to change the perceived standard of care
 as it relates to symptomatic pancreatic duct stones in this population, shifting the pendulum
 towards endoscopic and specifically pancreatoscopy-guided therapy.
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