Background: The migration rate of fully covered self-expandable metal stents (FCSEMSs) has been reported to be between 14% to 37%. Anchoring of FCSEMSs using a double-pigtail plastic stent (DPS) may decrease migration. Aim: To compare stent migration rates between patients who received FCSEMS alone and those who received both an FCSEMS and anchoring DPS. Methods: We conducted a retrospective analysis of endoscopy reporting system and medical records of 1366 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) with FCSEMS placement at the University of Kentucky health care. Between July 2015 and April 2017, 203 patients with FCSEMS insertion for the treatment of malignant biliary stricture, benign biliary stricture, post-sphincterotomy bleeding, bile leak, and cholangitis drainage were identified. The review and analysis were conducted through our endoscopy reporting system (ProVation® MD) and medical records. Categorical data were analyzed using Chi-Square and Fischer exact test and continuous data using nonparametric tests. A regression analysis was performed to identify factors independently associated with increased risk of stent migration. We determined an FCSEMS migration endoscopically if the stent was no longer visible in the major papilla. Results: 1366 patients had undergone ERCP by three advanced endoscopists over 21-mo period; among these, 203 patients had FCSEMSs placed. 65 patients had FCSEMSs with DPS, and 138 had FCSEMSs alone. 65 patients had FCSEMSs with DPS, and 138 had FCSEMSs alone. 95 patients had a malignant stricture, 82 patients had a benign stricture, 12 patients had bile leak, 12 patients had cholangitis, and nine patients had post-sphincterotomy bleeding. The migration rate in patients with anchored FCSEMSs with DPS was 6%, and those without anchoring DPS was 10% (P = 0.35). Overall, migration was reported in 18 patients with FCSEMSs placement out of 203 patients with an overall migration rate of 9.7%. There was no significant association between anchoring the FCSEMSs with DPS and the risk of stent migration. Only patients with the previous sphincterotomy and begin biliary stricture were found to have a statistically significant difference in the migration rate between patients who had FCSEMS with DPS and FCSEMS alone (P = 0.01). Conclusion: The risk of migration of biliary FCSEMS was 9.7 %. Anchoring an FCSEMS with DPS does not decrease the risk of stent migration
