Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study

Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study
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DOI:
10.1067/mge.2003.66
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发表时间:
2003-02-01
影响因子:
7.7
通讯作者:
Burtin, P
Burtin, P
中科院分区:
医学1区
文献类型:
--
作者:
Kaassis, M;Boyer, J;Burtin, P

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背景。与塑料支架相比,系统性使用金属支架治疗胆道梗阻受到成本高的限制。本研究的目的是比较塑料支架和金属支架治疗恶性胆总管狭窄患者的成本和疗效,并确定预测这些患者生存的因素。方法:118 名患有恶性胆总管狭窄的患者(平均年龄 75 岁)被随机分配放置塑料支架或金属支架。如所示,与 Mann-Whitney 或卡方检验进行了比较;生存率与 Cox 比例风险模型进行比较。结果:两组之间的生存率没有显着差异。金属支架组患者首次梗阻的时间较长(金属支架,中位未达到与塑料支架相比,5 个月;p = 0.007)。塑料支架组的额外住院天数、抗生素治疗天数以及 ERCP 和经腹超声手术的数量显着更高。经过多变量分析,只有肝转移的存在与生存独立相关(p < 0.0005;OR = 2.25)。该变量定义了生存期较短的群体。诊断时有肝转移的患者的中位生存期为 2.7 个月,而无肝转移患者的中位生存期为 5.3 个月;在后一组中,与金属支架相关的总体成本低于塑料支架。结论:金属支架置入是无法手术的恶性胆总管狭窄的最有效治疗方法。对于没有肝转移的患者,放置金属支架具有成本效益,而对于肿瘤扩散到肝脏的患者则应放置塑料支架。
Background. The systematic use of metal stents to treat biliary obstruction is restricted by high cost compared with plastic stents. The aims of this study were to compare cost and efficacy of plastic stents and metal stents in the treatment of patients with malignant common bile duct strictures and to define factors that predict survival of these patients.Methods: One hundred eighteen patients (mean age 75 years) with malignant strictures of the common bile duct were randomized to placement of a plastic stent or metal stent. Comparisons were made with the Mann-Whitney or chi-square test as indicated; survival rates were compared with a Cox proportional hazards model.Results: There was no significant difference in survival between the two groups. Time to first obstruction was longer for patients in the metal stent group (metal stent, median not reached vs. plastic stent, 5 months; p = 0.007). The number of additional days of hospitalization, days of antibiotic therapy, and the numbers of ERCPs and transabdominal US procedures was significantly higher in the plastic stent group. After multivariate analysis, only the presence of liver metastases was independently related to survival (p < 0.0005; OR = 2.25). This variable defined a group with a shorter survival. Median survival of patients with hepatic metastasis at diagnosis was 2.7 months compared with 5.3 months for patients without liver metastasis; in the latter group, the overall cost associated with metal stents was lower than for plastic stents.Conclusions: Metal stent placement is the most effective treatment of inoperable malignant common bile duct stricture. Placement of a metal stent is cost effective in patients without hepatic metastases, whereas a plastic stent should be placed in patients with spread of the tumor to the liver.