ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
Launched by UNIVERSITY OF COLORADO, DENVER · Oct 3, 2019
Trial Information
Current as of June 27, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 li...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Subjects aged 18-89
- • 2. 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
- • 3. Main PD stones in the head or body that are greater than 50% in size of the immediate downstream diameter of the pancreatic duct
- • 4. Stones ≥ 5 mm in diameter or impacted in the main PD on cross-sectional imaging or EUS
- Exclusion Criteria:
- • 1. Subjects who have previously received PPL or ESWL for PD stones within 12 months of enrollment
- • 2. Patients with PD stones isolated in the tail or side branches of the main duct
- • 3. 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
- • 4. Nontraversable ansa loop with upstream stones
- • 5. Inability to place a transpapillary pancreatic duct stent during ERP
- • 6. Patients with prior pancreatic surgery or surgically altered gastroduodenal anatomy, such as Roux-en-Y surgery
- • 7. Acquired pancreas divisum
- • 8. Significant cardiopulmonary co-morbidities precluding general anesthesia
- • 9. Patients with coagulation disorders that cannot be corrected to an INR below 2.0
- • 10. Patients with ongoing alcohol abuse and/or illicit drug use, except products containing THC
- • 11. Pregnancy
- • 12. Patients in active treatment for malignancy other than non-melanoma skin cancer or papillary thyroid cancer
About University Of Colorado, Denver
The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aurora, Colorado, United States
Patients applied
Trial Officials
Raj J Shah, MD
Principal Investigator
University of Colorado Anschutz Medical Campus, Professor of Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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