Digestive Disease Center and Research Institute, Department of Internal Medicine, Bucheon, Korea.
Surgery, SoonChunHyang University School of Medicine, Bucheon, Korea.
J Gastroenterol Hepatol. 2019 Sep;34(9):1590-1596. doi: 10.1111/jgh.14600. Epub 2019 Feb 27.
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.
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.
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).
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.
全覆膜自膨式金属支架(FCSEMS)在术前胆道引流(PBD)中可能优于塑料支架(PS),可缓解可切除恶性胆道梗阻(MBO)相关的胆管炎或黄疸。然而,需要对原本用于不可切除 MBO 的 FCSEMS 进行改良,使其成为合适的 PBD 支架。本研究旨在评估 12mm 直径、中央部分带有腰的非喇叭口改良 FCSEMS(M-FCSEMS)在可切除 MBO 患者中的应用是否优于 PS。
2015 年 8 月至 2017 年 12 月,85 例连续患者接受 PBD 联合手术治疗。在每个 M-FCSEMS 和 PS 组中,根据年龄、性别、体重指数以及术前白蛋白和胆红素水平,匹配 29 例患者。
M-FCSEMS 和 PS 组 PBD 的总体技术成功率均为 100%。两组手术时间相似(分别为 18.6±10.8 天和 19.3±11.6 天;P=0.843)。M-FCSEMS 组 PBD 相关不良事件(AE)发生率为 6.9%(2/29),PS 组为 27.6%(8/29)(P=0.037)。PS 组中有 20.7%(6/29)的患者需要在术前进行再次介入治疗,而 M-FCSEMS 组中没有患者需要再次介入治疗(P=0.023)。M-FCSEMS 和 PS 组围手术期 AE 发生率无差异(分别为 27.5%和 31.0%;P=0.773)。
与 PS 相比,改良 FCSEMS 可降低 PBD 相关 AE、再次介入治疗率,并具有可比较的围手术期 AE。M-FCSEMS 可能是可切除 MBO 患者 PBD 的一种新型支架。