Modified non-flared fully covered self-expandable metal stent versus plastic stent for preoperative biliary drainage in patients with resectable malignant biliary obstruction

Abstract

Background and aim: Fully covered self-expandable metal stents (FCSEMS) may be better than plastic stents (PS) for preoperative biliary drainage (PBD) to relieve cholangitis or jaundice for resectable malignant biliary obstruction (MBO). However, modification of current FCSEMS designed originally for nonresectable MBO is needed to be a proper stent for PBD. The aim of this study was to evaluate the possible superiority of non-flared modified FCSEMS (M-FCSEMS) with 12-mm diameter and waist of central portion over PS in patients with resectable MBO.

Methods: Eighty-five consecutive patients underwent PBD followed by operation from August 2015 to December 2017. In each M-FCSEMS and PS group, 29 patients were matched for age, sex, body mass index, and preoperative albumin and bilirubin levels.

Results: The overall technical success rates of PBD using M-FCSEMS and PS were 100%. The time to operation was similar between groups (18.6 ± 10.8 vs 19.3 ± 11.6 days, respectively; P = 0.843). The prevalence of PBD-related adverse events (AEs) was 6.9% (2/29) in the M-FCSEMS group versus 27.6% (8/29) in the PS group (P = 0.037). Re-intervention before operation was required in 20.7% (6/29) of patients in the PS group but no patients in the M-FCSEMS group (P = 0.023). No differences were found between perioperative AEs in the M-FCSEMS and PS groups (27.5% vs 31.0%, respectively; P = 0.773).

Conclusion: Modified FCSEMS led to lower PBD-related AEs, re-intervention rate, and comparable perioperative AEs compared with PS. M-FCSEMS may be a potential novel stent for PBD in patients with resectable MBO.

Keywords: adverse events; malignant biliary obstruction; preoperative biliary drainage; re-intervention; self-expandable metal stent.