By InvitationNot Applicable

ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis

United States150 participantsStarted 2020-01-02

Plain-language summary

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.

Who can participate

Age range18 Years – 89 Years

SexALL

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Inclusion criteria

✓. Subjects aged 18-89
✓. Subjects with abdominal pain secondary to chronic calcific pancreatitis and main pancreatic duct stones found on cross-sectional imaging, EUS, or ERP with upstream PD dilation
✓. Main PD stones in the head or body that are greater than 50% in size 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

Exclusion criteria

✕. Subjects who have previously received PPL or ESWL for PD stones within 12 months of enrollment
✕. Patients with PD stones isolated in the tail or side branches of the main duct
✕. Pancreatic tail stones comprising more than one-third of the stone burden within the main PD, if multiple locations of stones are noted within the main PD
✕. Nontraversable ansa loop with upstream stones
✕. Inability to place a transpapillary pancreatic duct stent during ERP
✕. Patients with prior pancreatic surgery or surgically altered gastroduodenal anatomy, such as Roux-en-Y surgery
✕. Acquired pancreas divisum
✕. Significant cardiopulmonary co-morbidities precluding general anesthesia

What they're measuring

Stone Clearance Rate

Timeframe: Up to 4 hours (four 1-hour sessions)

Trial details

NCT IDNCT04115826

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Pancreatitis, Chronic trials