A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction
A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction
复制标题
DOI：
10.1016/j.gie.2010.08.021
复制
发表时间：
2010-11-01
影响因子：
7.7
通讯作者：
Brugge, William R.
中科院分区：
文献类型：
--
作者：
Telford, Jennifer J.;Carr-Locke, David L.;Brugge, William R.
背景：无覆膜胆道自膨式金属支架（SEMS）最常见的并发症是肿瘤长入。增加不可穿透的覆盖物可能延长支架的通畅性。目的：比较恶性胆道梗阻中未覆盖和部分覆盖的SEMS之间的支架通畅性。设计：多中心随机试验。设置：四家教学医院。患者：患有无法手术的远端恶性胆道梗阻的成人。干预：未覆盖或部分覆盖的SEMS插入。主要结局指标：胆道梗阻复发时间、患者生存率、严重不良事件和胆道梗阻复发机制。结果：从2002年10月至2008年5月，129例患者被随机分组。在61例未覆盖的SEMSs中有11例（18%）和68例部分覆盖的SEMSs中有20例（29%）观察到复发性胆道梗阻。未覆盖和部分覆盖SEMS组的复发性胆道梗阻的中位时间分别为711天和357天（P = .530）。未覆盖SEMS组的中位患者生存期为239天，部分覆盖SEMS组为227天（P = 0.997）。未覆盖和部分覆盖SEMS组分别有27例（44%）和42例（62%）患者发生严重不良事件（P = 0.046）。无未覆盖和8例（12%）部分覆盖的SEM发生移位（P = 0.0061）。局限性：未达到预期样本量。分配到治疗组是不平等的。结论：有没有显着差异的时间复发性胆道梗阻或患者生存率之间的部分覆盖和未覆盖的SEMS组。部分覆盖的SES与更严重的不良事件相关，尤其是移位。（临床试验注册号：NCT 01047332。）（Gastrointest Endosc 2010;72：907-14.）
Background: The most common complication of uncovered biliary self-expandable metal stents (SEMSs) is tumor ingrowth. The addition of an impenetrable covering may prolong stent patency.Objective: To compare stent patency between uncovered and partially covered SEMSs in malignant biliary obstruction.Design: Multicenter randomized trial.Setting: Four teaching hospitals.Patients: Adults with inoperable distal malignant biliary obstruction.Interventions: Uncovered or partially covered SEMS insertion.Main Outcome Measures: Time to recurrent biliary obstruction, patient survival, serious adverse events, and mechanism of recurrent biliary obstruction.Results: From October 2002 to May 2008, 129 patients were randomized. Recurrent biliary obstruction was observed in 11 of 61 uncovered SEMSs (18%) and 20 of 68 partially covered SEMSs (29%). The median times to recurrent biliary obstruction were 711 days and 357 days for the uncovered and partially covered SEMS groups, respectively (P = .530). Median patient survival was 239 days for the uncovered SEMS and 227 days for the partially covered SEMS groups (P = .997). Serious adverse events occurred in 27 (44%) and 42 (62%) patients in the uncovered and partially covered SEMS groups, respectively (P = .046). None of the uncovered and 8 (12%) of the partially covered SEMSs migrated (P = .0061).Limitations: Intended sample size was not reached. Allocation to treatment groups was unequal.Conclusions: There was no significant difference in time to recurrent biliary obstruction or patient survival between the partially covered and uncovered SEMS groups. Partially covered SEMSs were associated with more serious adverse events, particularly migration. (Clinical trial registration number: NCT01047332.) (Gastrointest Endosc 2010;72:907-14.)