1. Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial.
- Author
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Sherman S, Kozarek RA, Costamagna G, Reddy DN, Tarnasky P, Shah RJ, Slivka A, Fogel E, Watkins J, Delhaye M, Irani SS, Tringali A, Lakhtakia S, Kedia P, Edmundowicz S, Peetermans JA, Rousseau MJ, and Devière J
- Subjects
- Humans, Adult, Middle Aged, Aged, Pancreatic Ducts, Constriction, Pathologic therapy, Constriction, Pathologic complications, Prospective Studies, Treatment Outcome, Stents adverse effects, Pain etiology, Plastics, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Self Expandable Metallic Stents adverse effects, Pancreatitis, Chronic complications, Gastrointestinal Diseases etiology
- Abstract
Background and Aims: 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., Methods: 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 <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent., Results: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65)., Conclusions: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection. (Clinical trial registration number: NCT02802020.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. All rights reserved.)
- Published
- 2023
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