Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Department of Gastroenterology, International Medical Center, Saitama Medical University, 1397-1, Yamane, Hidaka-shi, Saitama, Japan.
Dig Dis Sci. 2018 Sep;63(9):2466-2473. doi: 10.1007/s10620-017-4875-5. Epub 2017 Dec 7.
Both fully covered (FC) and partially covered (PC) self-expandable metal stents (SEMSs) are now commercially available for distal malignant biliary obstruction (MBO). While FCSEMS can be easily removed at the time of re-interventions, it is theoretically prone to migration. However, few comparative data between FC and PC SEMSs have been reported.
The aim of this study was to compare clinical outcomes of FCSEMS with those of PCSEMS.
This was a multicenter, prospective study of FCSEMS for unresectable distal MBO with a historical control of PCSEMS, which was previously reported as the WATCH study. The primary outcome was recurrent biliary obstruction (RBO), and secondary outcomes were stent migration, stent removal, stent-related adverse events, and survival.
A total of 151 cases with unresectable distal MBO undergoing FCSEMS placement were enrolled and compared with a historical cohort of 141 cases undergoing PCSEMS placement. No significant differences were found in the rate of RBO (29 vs. 33%; P = 0.451), time to RBO (318 vs. 373 days; P = 0.382), and survival (229 vs. 196 days; P = 0.177) between FCSEMS and PCSEMS. The rate of stent migration also did not differ significantly between the two groups (14 vs. 8%; P = 0.113). The removal of FCSEMSs was successful in all 24 attempted cases (100%).
FCSEMSs appeared comparable to PCSEMSs in terms of RBO without a significant increase in stent migration rate in patients with unresectable distal MBO.
UMIN000007131.
完全覆膜（FC）和部分覆膜（PC）自膨式金属支架（SEMS）现已可用于治疗远端恶性胆道梗阻（MBO）。虽然 FCSEMS 可在再次介入时轻松取出，但理论上易发生迁移。然而，关于 FC 和 PC SEMS 之间的比较数据很少。
本研究旨在比较 FCSEMS 与 PCSEMS 的临床疗效。
这是一项多中心、前瞻性研究，纳入了 151 例不可切除的远端 MBO 患者，采用 FCSEMS 治疗，并与之前报道的 PCSEMS 作为历史对照（WATCH 研究）进行比较。主要结局为复发性胆道梗阻（RBO），次要结局为支架迁移、支架取出、支架相关不良事件和生存。
共纳入 151 例接受 FCSEMS 治疗的不可切除的远端 MBO 患者，并与 141 例接受 PCSEMS 治疗的历史队列进行比较。两组 RBO 发生率（29% vs. 33%；P=0.451）、RBO 时间（318 天 vs. 373 天；P=0.382）和生存时间（229 天 vs. 196 天；P=0.177）差异均无统计学意义。两组支架迁移率也无显著差异（14% vs. 8%；P=0.113）。24 例尝试取出 FCSEMS 的患者均成功取出（100%）。
在不可切除的远端 MBO 患者中，FCSEMS 与 PCSEMS 相比，RBO 无显著增加，且支架迁移率无显著增加。
UMIN000007131。
