Per-oral pancreatoscopy-guided lithotripsy vs. extracorporeal shock wave lithotripsy for treating refractory main pancreatic duct stones in chronic pancreatitis: Protocol for an open-label multi-center randomized clinical trial |
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| Institution: | 1. Division of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, OH, United States;2. Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, CO, United States;3. Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, MD, United States;4. Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Minneapolis, MN, United States;5. Division of Gastroenterology, Rutgers Robert Wood Johnson, New Brunswick, NJ, United States;6. Division of Gastroenterology, Baylor College of Medicine, Houston, TX, United States;7. Division of Gastroenterology, UT Health San Antonio, San Antonio, TX, United States;8. Division of Gastroenterology, Baylor St. Luke''s Medical Center, Houston, TX, United States;9. Department of Urology, University of Colorado Anschutz Medical Campus, Aurora, CO, United States;10. Division of Gastroenterology, Methodist Dallas Medical Center, Dallas, TX, United States;1. Division of Oncology and Hematology, Okinawa Chubu Hospital, Okinawa, Japan;2. Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan;3. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan;4. Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan;5. Department of Biostatistics, Clinical Research Support Center, Shizuoka Cancer Center, Shizuoka, Japan;6. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan;7. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan;8. Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan;9. Hepato-Biliary-Pancreatic Medicine Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan;10. Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan;11. Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan;12. Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan;13. Division of Cancer Center, Hokkaido University Hospital, Sapporo, Japan;14. Department of Gastroenterology, Kanazawa University, Kanazawa, Japan;15. Department of Gastroenterological Oncology, Hyogo Cancer Center, Hyogo, Japan;p. Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan;q. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan;r. Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan;s. Department of Gastroenterology, National Center for Global Health and Medicine, Tokyo, Japan;t. Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan;u. Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan;v. Department of Hepato-Biliary-Pancreatology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan;w. Department of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan;x. Department of Gastroenterology, Fukushima Medical University, School of Medicine, Fukushima, Japan;y. Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan;1. Department of Radiology, Cincinnati Children''s Hospital Medical Center, Cincinnati, OH, USA;2. Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA;3. Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA;4. Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children''s Hospital Medical Center, Cincinnati, OH, USA;5. Division of Endocrinology, Cincinnati Children''s Hospital Medical Center, Cincinnati, OH, USA;6. Division of Pediatric General and Thoracic Surgery, Cincinnati Children''s Hospital Medical Center, Cincinnati, OH, USA;1. Department of HPB Surgery and Transplantation, La Fe University Hospital and University of Valencia, Valencia, Spain;2. Department of General and Pancreatic Surgery, Verona Hospital Trust, University of Verona, Verona, Italy;3. Department of Nephrology and Kidney Transplantation, La Fe University Hospital and University of Valencia, Valencia, Spain;4. Department of Endocrinology, La Fe University Hospital and University of Valencia, Valencia, Spain;1. First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan;2. Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, Japan;3. Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan |
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| Abstract: | Backgrounds/ObjectivesPatients with chronic pancreatitis may develop pancreatic duct stones that can obstruct outflow leading to ductal hypertension and pain. Both endoscopic retrograde pancreatography (ERP) with per-oral pancreatoscopy (POP) and intraductal lithotripsy and extracorporeal shock wave lithotripsy (ESWL) are feasible options to attempt ductal stone clearance. This study aims to compare POP-guided lithotripsy with ESWL in the management of refractory symptomatic main pancreatic duct stones.MethodsThis is an open-label, multi-center, parallel, randomized clinical trial. Patients with chronic pancreatitis and main pancreatic duct stones ≥5 mm who fail standard ERP methods for stone removal will be eligible for this study. In total, 150 subjects will be randomized 1:1 to either ESWL or POP. A maximum of 4 sessions of either ESWL or POP will be allowed in each arm, with crossover permitted thereafter. The primary outcome is complete stone clearance and secondary outcomes include quality of life, pain scores, number of interventions, and daily opiate requirements.ConclusionsThis study aims to answer the question of which lithotripsy method is superior in removing refractory pancreatic duct stones while addressing the effects of lithotripsy on quality of life and pain in patients with chronic calcific pancreatitis (ClinicalTrials.gov NCT04115826). |
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| Keywords: | Chronic pancreatitis Pancreatic duct stone Laser lithotripsy Extracorporeal shock-wave lithotripsy Electrohydraulic lithotripsy |
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