OBJECTIVES: To evaluate whether laser-cut covered self-expandable metallic stents (LC-CSEMSs) can be the first choice for patients with unresectable distal malignant biliary obstruction (DMBO). METHODS: Patients with unresectable DMBO who received LC-CSEMS (September 2014-December 2020) or braided CSEMS (B-CSEMS) (July 2013-December 2020) placement for biliary drainage were enrolled. Outcomes, including endoscopic CSEMS removal, of LC-CSEMSs and B-CSEMSs were compared. RESULTS: Overall, 124 patients received LC-CSEMSs placement, and 121 B-CSEMSs. Technical success, clinical success, and procedure-related adverse event rates with LC-CSEMSs were 100%, 96.8%, and 6.5%, respectively, and 100%, 95.9%, and 5.8%, respectively, for B-CSEMSs, with no significant difference (P > .99, .75, and >.99, respectively). The recurrent biliary obstruction (RBO) rates with LC-CSEMSs and B-CSEMSs were 9.7% (12/124) and 13.2% (16/121), respectively (P = .43). The median time to RBO with LC-CSEMSs and B-CSEMSs was 198 (interquartile range [IQR], 124-244) days and 191 (IQR, 106-271) days (P = .41). The endoscopic removal success rates of LC-CSEMSs and B-CSEMSs were 88.9% (8/9) and 90% (9/10) (P > .99), although there were a small number of cases. CONCLUSIONS: The non-inferiority of LC-CSEMSs was proven. LC-CSEMSs can be considered as the first choice for patients with unresectable DMBO.
OBJECTIVES: To evaluate whether laser-cut covered self-expandable metallic stents (LC-CSEMSs) can be the first choice for patients with unresectable distal malignant biliary obstruction (DMBO). METHODS: Patients with unresectable DMBO who received LC-CSEMS (September 2014-December 2020) or braided CSEMS (B-CSEMS) (July 2013-December 2020) placement for biliary drainage were enrolled. Outcomes, including endoscopic CSEMS removal, of LC-CSEMSs and B-CSEMSs were compared. RESULTS: Overall, 124 patients received LC-CSEMSs placement, and 121 B-CSEMSs. Technical success, clinical success, and procedure-related adverse event rates with LC-CSEMSs were 100%, 96.8%, and 6.5%, respectively, and 100%, 95.9%, and 5.8%, respectively, for B-CSEMSs, with no significant difference (P > .99, .75, and >.99, respectively). The recurrent biliary obstruction (RBO) rates with LC-CSEMSs and B-CSEMSs were 9.7% (12/124) and 13.2% (16/121), respectively (P = .43). The median time to RBO with LC-CSEMSs and B-CSEMSs was 198 (interquartile range [IQR], 124-244) days and 191 (IQR, 106-271) days (P = .41). The endoscopic removal success rates of LC-CSEMSs and B-CSEMSs were 88.9% (8/9) and 90% (9/10) (P > .99), although there were a small number of cases. CONCLUSIONS: The non-inferiority of LC-CSEMSs was proven. LC-CSEMSs can be considered as the first choice for patients with unresectable DMBO.