Soft Self-expanding Metal Stent to Treat Painful Pancreatic Duct Strictures Secondary to Chronic Pancreatitis: A Prospective Multicenter Trial

Published:October 05, 2022DOI:
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      Background & Aims

      Fully covered self-expanding metal stents (FCSEMS) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection, 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 enrolled in a prospective multicenter single-arm trial studying 6-month indwell of a 4-6 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 to be assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent.


      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 patients) and safety (31.3%, 21/67 patients) endpoints failed to meet the a priori study hypotheses. Study stent migration occured in 47.7% (31/65) patients.


      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.

      Key words

      Acronyms and abbreviations:

      CDM (complete distal migration), CI (confidence interval), CP (chronic pancreatitis), ERCP (endoscopic retrograde cholangiopancreatography), ESWL (extracorporeal shock wave lithotripsy), EUS (endoscopic ultrasound), FCSEMS (fully covered self-expanding metal stent), FDA (US Food and Drug Administration), IDE (Investigational Device Exemption), ITT (intention to treat), MME (morphine milligram equivalents), PD (pancreatic duct), PG (performance goal), QOL (quality of life), RCT (randomized clinical trial), SAE (serious adverse event), SAS (Statistical Analysis System), SD (standard deviation), VAS (Visual Analogue Scale)
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