Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial

• Published in: Gastrointestinal endoscopy 2023-03, Vol.97 (3), p.472-481.e3
• Main Authors: Sherman, Stuart, Kozarek, Richard A., Costamagna, Guido, Reddy, D. Nageshwar, Tarnasky, Paul, Shah, Raj J., Slivka, Adam, Fogel, Evan, Watkins, James, Delhaye, Myriam, Irani, Shayan S., Tringali, Andrea, Lakhtakia, Sundeep, Kedia, Prashant, Edmundowicz, Steven, Peetermans, Joyce A., Rousseau, Matthew J., Devière, Jacques
• Format: Article
• Language: English
• Subjects: Adult; Aged; Cholangiopancreatography, Endoscopic Retrograde - adverse effects; Constriction, Pathologic - complications; Constriction, Pathologic - therapy; Gastrointestinal Diseases - etiology; Humans; Middle Aged; Pain - etiology; Pancreatic Ducts; Pancreatitis, Chronic - complications; Plastics; Prospective Studies; Self Expandable Metallic Stents - adverse effects; Stents - adverse effects; Treatment Outcome
• ISSN: 0016-5107; 1097-6779
• DOI: 10.1016/j.gie.2022.09.021

Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain. Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting–related serious adverse events (SAEs), respectively (performance goal