Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry

Gastrointest Endosc. 2016 Sep;84(3):450-457.e2. doi: 10.1016/j.gie.2016.02.044. Epub 2016 Mar 10.


Background and aims: Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior.

Methods: This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery.

Results: The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome.

Conclusions: An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome.

MeSH terms

  • Aged
  • Databases, Factual
  • Digestive System Surgical Procedures / instrumentation
  • Digestive System Surgical Procedures / methods
  • Drainage / instrumentation*
  • Drainage / methods
  • Endosonography
  • Female
  • Humans
  • Male
  • Middle Aged
  • Necrosis
  • Pancreas / pathology
  • Pancreas / surgery*
  • Pancreatic Pseudocyst / surgery*
  • Registries*
  • Retrospective Studies
  • Risk Factors
  • Self Expandable Metallic Stents*
  • Spain
  • Surgery, Computer-Assisted / instrumentation
  • Surgery, Computer-Assisted / methods
  • Treatment Outcome