ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
Unknown statusNot applicableNCT04115826
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Per-oral Pancreatoscopy-guided Lithotripsy vs. Extracorporeal Shock Wave Lithotripsy in Chronic Pancreatitis
- Conditions
- Pancreatitis, Chronic
- Interventions
- Procedure: Per-oral Pancreatoscopy-guided Lithotripsy
- Procedure: Extracorporeal Shock-Wave Lithotripsy
- Sponsor
- University of Colorado, Denver
- Start date
- 2020-01-02
- Primary completion
- 2025-03-31
- Sex
- All
- Age range
- from 18 Years to 89 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04115826