Phase I trial of a temporary ureteral drainage stent.
Phase I trial of a temporary ureteral drainage stent.
复制标题
临时输尿管引流支架的一期试验。
DOI：
10.1089/089277903321618734
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发表时间：
2003
影响因子：
2.7
通讯作者：
R. Kuo
中科院分区：
文献类型：
--
作者：
J. Lingeman;D. Schulsinger;R. Kuo
背景和目的
临时输尿管引流支架（TUDS; Boston Scientific/Microvasive，Natick，MA）是一种可生物降解的器械，设计用于保持通畅48小时，随后逐渐软化并自发排出。我们在I期临床试验中评价了TUDS的耐久性、通畅性和安全性。
患者和方法
18例因复杂结石病需要序贯经皮肾镜取石术（PNL）的结石患者在初始经皮治疗后接受了顺行TUDS置入。在21次尝试中放置了19件器械，其中1例患者接受了双侧TUDS放置。进行第2天肾造影，以评估支架状态并证明顺行血流。在二次PNL时（第2或3天）取出支架。
结果
TUDS置入过程中无并发症发生。第2天，1枚支架进入膀胱。11个支架完全完整，7个支架部分完整。在所有19个支架输尿管中均显示第2天输尿管通畅。在二次PNL期间，18个TUDS被完全取出，其中1个发生部分保留。1个月时，所有患者的所有支架材料均已排出体外。没有不良事件可归因于TUDS。
结论
TUDS似乎有助于输尿管引流至少48小时后放置。尽管偶尔观察到支架尾部脱粘，但这些并未干扰器械功能。TUDS的安全性是有利的，没有可归因于器械本身的并发症。基于这些初步发现，对接受不复杂输尿管镜操作后逆行放置TUDS的患者进行更大规模的前瞻性临床研究似乎是合适的。
BACKGROUND AND PURPOSE
The temporary ureteral drainage stent (TUDS; Boston Scientific/Microvasive, Natick, MA) is a biodegradable device that is designed to maintain patency for 48 hours with gradual softening and spontaneous expulsion thereafter. We evaluated the durability, patency, and safety of TUDS in a Phase I clinical trial.
PATIENTS AND METHODS
Eighteen stone patients requiring sequential percutaneous nephrolithotomies (PNL) for complex stone disease underwent antegrade TUDS placement following initial percutaneous treatment. Nineteen devices were placed in 21 attempts, with one patient undergoing bilateral TUDS placement. Day 2 nephrostograms were performed to allow assessment of stent status and to demonstrate antegrade flow. Stents were removed at the time of the secondary PNL (day 2 or 3).
RESULTS
No complications occurred during TUDS placement. On day 2, 1 stent had passed into the bladder. Eleven stents were completely intact, with seven others partially intact. Day 2 ureteral patency was demonstrated in all 19 stented ureters. Eighteen TUDS were removed completely during the secondary PNL with one incident of partial retention. All stent material had passed out of the body in all patients by 1 month. No adverse events were attributable to the TUDS.
CONCLUSIONS
The TUDS appears to facilitate ureteral drainage for at least 48 hours after placement. Although occasional stent tail detachments were noted, these did not interfere with device function. The safety profile of TUDS was favorable, with no complications attributable to the device itself. A larger prospective clinical study in patients receiving TUDS placed retrograde after uncomplicated ureteroscopic manipulation appears appropriate on the basis of these initial findings.