A prospective randomised study of "covered'' versus "uncovered'' diamond stents for the management of distal malignant biliary obstruction
A prospective randomised study of "covered'' versus "uncovered'' diamond stents for the management of distal malignant biliary obstruction
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DOI：
10.1136/gut.2003.018945
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发表时间：
2004-05-01
期刊：
影响因子：
24.5
通讯作者：
Omata, M
中科院分区：
文献类型：
--
作者：
Isayama, H;Komatsu, Y;Omata, M
背景与目的：覆盖自扩展金属支架（EMS）最近被开发用于克服传统EMS中的肿瘤向内生长。然而，缺乏支持覆盖的EMS有效性的证据。患者和方法：我们招募了112例不可切除的胆道远端恶性肿瘤患者。他们被随机分配到聚氨酯覆盖组（n = 57）或原始金刚石支架组（n = 55）。结果：覆盖组有8例患者（14%）在平均304天后发生支架闭塞，未覆盖组有21例患者（38%）在平均166天后发生支架闭塞。覆盖EMS闭塞发生率显著低于未覆盖EMS闭塞发生率（p = 0.0032）。有盖支架的累积支架通畅度显著高于无盖支架（p = 0.0066）。遮盖组无肿瘤长入，而未遮盖组有15例患者肿瘤长入。在亚组分析中，覆盖的EMS的累积通畅度在胰腺癌（p = 0.0363）和转移性淋巴结（p = 0.0354）中显著更高。两组患者的生存率无显著差异。有盖组有2例急性胆囊炎，无盖组无急性胆囊炎。轻度胰腺炎发生在五个覆盖组和一个未覆盖组。结论：覆盖型金刚石支架成功阻止肿瘤向内生长，治疗远端恶性胆道梗阻的效果明显优于无覆盖型支架。然而，必须特别注意覆盖自膨胀金属支架的并发症，如急性胆囊炎和胰腺炎。
Background and aim: Covered self-expandable metal stents (EMS) were recently developed to overcome tumour ingrowth in conventional EMS. However, supporting evidence for the efficacy of covered EMS is lacking.Patients and methods: We enrolled 112 patients with unresectable distal biliary malignancies. They were randomly assigned to polyurethane covered (n = 57) or original diamond stent (n = 55).Results: Stent occlusion occurred in eight patients (14%) after a mean of 304 days in the covered group, and in 21 patients (38%) after a mean of 166 days in the uncovered group. The incidence of covered EMS occlusion was significantly lower than that of uncovered EMS (p = 0.0032). The cumulative stent patency of covered stents was significantly higher than that of uncovered stents (p = 0.0066). No tumour ingrowth occurred in the covered group while it was observed in 15 patients in the uncovered group. In subgroup analysis, the cumulative patency of the covered EMS was significantly higher in pancreatic cancer (p = 0.0363) and metastatic lymph nodes (p = 0.0354). There was no significant difference in survival between the two groups. Acute cholecystitis was observed in two of the covered group and in none of the uncovered group. Mild pancreatitis occurred in five of the covered group and in one of the uncovered group.Conclusions: Covered diamond stents successfully prevented tumour ingrowth and were significantly superior to uncovered stents for the treatment of patients with distal malignant biliary obstruction. However, careful attention must be paid to complications specific to covered self-expandable metal stents, such as acute cholecystitis and pancreatitis.