Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Gastrointest Endosc. 2012 Jul;76(1):84-92. doi: 10.1016/j.gie.2012.02.039. Epub 2012 Apr 5.
Covered self-expandable metal stents (CSEMSs) were developed to prevent tumor ingrowth, but stent migration is one of the problems with CSEMSs.
To evaluate a new, commercially available CSEMS with flared ends and low axial force compared with a commercially available CSEMS without the anti-migration system and high axial force.
Multicenter, prospective study with a historical cohort.
Twenty Japanese referral centers.
This study involved patients with unresectable distal malignant biliary obstruction.
Placement of a new, commercially available, partially covered SEMS.
Recurrent biliary obstruction rate, time to recurrent biliary obstruction, stent-related complications, survival.
Between April 2009 and March 2010, 141 patients underwent partially covered nitinol stent placement, and between May 2001 and January 2007, 138 patients underwent placement of partially covered stainless stents as a historical control. The silicone cover of the partially covered nitinol stents prevented tumor ingrowth. There were no significant differences in survival (229 vs 219 days; P = .250) or the rate of recurrent biliary obstruction (33% vs 38%; P = .385) between partially covered nitinol stents and partially covered stainless stents. Stent migration was less frequent (8% vs 17%; P = .019), and time to recurrent biliary obstruction was significantly longer (373 vs 285 days; P = .007) with partially covered nitinol stents. Stent removal was successful in 26 of 27 patients (96%).
Nonrandomized, controlled trial.
Partially covered nitinol stents with an anti-migration system and less axial force demonstrated longer time to recurrent biliary obstruction with no tumor ingrowth and less stent migration.
带覆膜的自膨式金属支架（CSEMS）的开发是为了防止肿瘤向内生长，但支架迁移是 CSEMS 的问题之一。
与不带抗迁移系统和高轴向力的市售 CSEMS 相比，评估一种新的、市售的带喇叭口和低轴向力的 CSEMS。
多中心、前瞻性研究，有历史对照队列。
日本 20 家转诊中心。
本研究纳入了无法切除的远端恶性胆道梗阻患者。
放置一种新的、市售的部分覆膜 SEMS。
复发性胆道梗阻率、复发性胆道梗阻时间、支架相关并发症、生存率。
2009 年 4 月至 2010 年 3 月期间，141 例患者接受了部分覆膜镍钛合金支架置入术，2001 年 5 月至 2007 年 1 月期间，138 例患者接受了部分覆膜不锈钢支架置入术作为历史对照。部分覆膜镍钛合金支架的硅酮覆膜可防止肿瘤向内生长。部分覆膜镍钛合金支架和部分覆膜不锈钢支架在生存率（229 天比 219 天；P =.250）或复发性胆道梗阻发生率（33%比 38%；P =.385）方面无显著差异。支架迁移的发生率较低（8%比 17%；P =.019），复发性胆道梗阻时间明显较长（373 天比 285 天；P =.007）。27 例患者中有 26 例（96%）成功取出支架。
非随机对照试验。
带抗迁移系统和较低轴向力的部分覆膜镍钛合金支架可防止肿瘤向内生长和支架迁移，且复发性胆道梗阻时间更长。
