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A prospective randomised multicentre trial comparing 10 Fr Teflon Tannenbaum stents with 10 Fr polyethylene Cotton-Leung stents in patients with malignant common duct strictures

机译:一项前瞻性随机多中心试验比较了恶性总管狭窄患者的10 Fr Teflon Tannenbaum支架与10 Fr聚乙烯棉梁支架

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摘要

BACKGROUND—Stent blockage is a multifactorial process in which stent design and materials, bacteria, proteins, and bile viscosity play a role.
AIMS—To compare the patency of the 10 Fr Teflon Tannenbaum (TT) stent to that of the 10 Fr Cotton-Leung (CL) polyethylene stent with sideholes, in patients with malignant obstructive jaundice.
METHODS—Patients were recruited to this prospective multicentre randomised study if they had a newly diagnosed malignant bile duct stricture below the hilum of the liver suitable for stenting with a 10 Fr stent. Data were collected and monitored by a professional monitoring company. Primary patency was the interval between stent placement and first exchange or death without recurrent jaundice.
RESULTS—134 consecutive patients were recruited between November 1994 and June 1997; 65 were randomised to the TT stent and 69 to the CL stent. Median patency and 95% confidence intervals were 181 (59, 303) days for the TT stent and 133 (92, 174) days for the CL stent, with no significant difference between the two stents (p=0.49). Median survival and 95% confidence intervals were 115 (71, 159) days for the TT stent and 151 (112, 190) days for the CL stent, with no significant difference between the two stents (p=0.765).
CONCLUSION—Neither Teflon as a stent material nor the Tannenbaum design prolong the patency of plastic stents.


>Keywords: biliary prosthesis; patency; bile duct malignancy
机译:背景-支架阻塞是一个多因素过程,其中支架的设计和材料,细菌,蛋白质和胆汁的黏度起着作用。
目的-比较10 Fr Teflon Tannenbaum(TT)支架与支架的通畅性10带有棉孔的棉绒(CL)聚乙烯支架在患有恶性阻塞性黄疸的患者中的应用。肝脏适合用10 Fr支架置入支架。数据由专业的监控公司收集和监控。主要通畅程度是支架置入与首次更换或死亡之间的间隔,而无复发性黄疸。
结果-1994年11月至1997年6月间连续招募了134例患者。 65随机分配给TT支架,69随机分配给CL支架。 TT支架的中位通畅度和95%置信区间为181支架天(181,59,303)天,CL支架为133(92,174)天,两个支架之间无显着差异(p = 0.49)。 TT支架的中位生存期和95%置信区间为115 (71,159)天,CL支架为151(112,190)天,两个支架之间无显着差异(p = 0.765)。
结论—特氟隆作为支架材料或Tannenbaum设计都不能延长塑料支架的开放性。


>关键词:通畅;胆管恶性肿瘤

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