Status:
ENROLLING_BY_INVITATION
ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
Lead Sponsor:
University of Colorado, Denver
Conditions:
Pancreatitis, Chronic
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief 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 chroni...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- Patients with coagulation disorders that cannot be corrected to an INR below 2.0
- Patients with ongoing alcohol abuse and/or illicit drug use, except products containing THC
- Pregnancy
- Patients in active treatment for malignancy other than non-melanoma skin cancer or papillary thyroid cancer
Key Trial Info
Start Date :
January 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04115826
Start Date
January 2 2020
End Date
June 30 2026
Last Update
May 22 2024
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045