Harper Jonathan D, Ebrahimi Kamyar Y, Auge Brian K, Lamberton Gregory R, Pham Angie K, Zuppan Craig, Albala David M, Preminger Glenn M, Baldwin D Duane
Division of Urology, Loma Linda University School of Medicine, Loma Linda, California 92354, USA.
J Urol. 2008 May;179(5):2042-5. doi: 10.1016/j.juro.2007.12.042. Epub 2008 Mar 19.
Traditional ureteral access sheaths rely on tapered dilators and the Dotter principle of axial force to gain access into the ureter. We compared the performance of a novel balloon expandable ureteral access sheath using radial dilatation with that of a conventional ureteral access sheath.
Ten farm pigs underwent randomized placement of the novel sheath in 1 ureter and a conventional ureteral access sheath in the contralateral ureter followed by videotaped ureteroscopy. Acute study end points included maximum and mean force of sheath insertion and removal, saline flow rate and subjective urothelial damage following sheath insertion/inflation. Additionally, blinded reviewers rated urothelial damage on digitally recorded video following sheath removal. Chronic data included gross and histological ureteral analysis at 30 days.
The novel ureteral access sheath inserted with less maximum force (0.36 vs 1.48 pounds, p <0.001) and less average force (0.11 vs 0.49 pounds, p = 0.001). The flow rate during 5 minutes was higher in the new sheath (90.0 vs 80.6 cc per minute, p <0.05). Withdrawal forces were not statistically different between the sheaths. The novel sheath also had a lower subjective trauma scale rating (4.2 vs 6.1, p <0.05). Eight blinded reviewers determined that the novel ureteral access sheath resulted in less total urothelial tear length (1.3 vs 2.7 cm, p = 0.03) and less visible ureteral damage in all animals except 1 (p = 0.04).
The novel balloon expandable ureteral access sheath had easier insertion and a better flow rate, and caused less urothelial trauma in this porcine model. This ureteral access sheath offers a promising new option for ureteral access. A randomized clinical trial is in progress to assess the benefits of this new ureteral access sheath.
传统输尿管通路鞘依靠锥形扩张器和轴向力的多特原理进入输尿管。我们比较了一种新型球囊扩张输尿管通路鞘采用径向扩张与传统输尿管通路鞘的性能。
10头家猪被随机在一侧输尿管置入新型鞘，对侧输尿管置入传统输尿管通路鞘，随后进行输尿管镜录像检查。急性研究终点包括鞘插入和拔出的最大及平均力、盐水流速以及鞘插入/充气后主观的尿路上皮损伤。此外，在鞘拔出后，由不知情的评审人员根据数字记录的视频对尿路上皮损伤进行评分。慢性数据包括30天时输尿管的大体和组织学分析。
新型输尿管通路鞘插入时的最大力较小（0.36磅对1.48磅，p<0.001），平均力也较小（0.11磅对0.49磅，p = 0.001）。新型鞘在5分钟内的流速更高（每分钟90.0毫升对80.6毫升，p<0.05）。鞘拔出时的力在两种鞘之间无统计学差异。新型鞘的主观创伤评分也较低（4.2对6.1，p<0.05）。8名不知情的评审人员确定，新型输尿管通路鞘导致的尿路上皮撕裂总长度较短（1.3厘米对2.7厘米，p = 0.03），除1只动物外，所有动物的输尿管可见损伤均较少（p = 0.04）。
在该猪模型中，新型球囊扩张输尿管通路鞘插入更容易，流速更好，且对尿路上皮的创伤更小。这种输尿管通路鞘为输尿管通路提供了一个有前景的新选择。一项随机临床试验正在进行，以评估这种新型输尿管通路鞘的益处。
