May A, Ell C
Dept. of Internal Medicine II, HSK Wiesbaden (Teaching Hospital of Johannes Gutenberg University, Mainz), Germany.
Endoscopy. 2004 Apr;36(4):329-33. doi: 10.1055/s-2004-814206.
The JoStent SelfX is a new biliary uncovered self-expanding nitinol stent. The main advantage of this stent in comparison with the "gold standard" Wallstent is the minimal shortening (< 10 %) that occurs during stent deployment. A prospective feasibility study was conducted to evaluate the method of stent implantation and the stent's short-term efficacy.
Between April 2001 and December 2002, the JoStent SelfX was implanted in 20 patients with inoperable malignant biliary obstructions, mainly caused by pancreatic cancer (12 of 20). All patients underwent sphincterotomy prior to stent insertion. After implantation, laboratory parameters for cholestasis and expansion of the stent were checked over a period of several days. All patients were followed for 8 weeks after implantation to document early stent dysfunction.
Stent implantation was easily managed and successful in all patients, with no technical problems. Prior bougienage was required in only one patient, who had a filiform stenosis. No stent retraction was observed during stent release. All stents showed full expansion within 5 days. No acute complications occurred. Adequate reduction in the elevated laboratory parameters for cholestasis was observed. Two patients had recurrent cholestasis and fever due to cholangitis, or stent occlusion caused by biliary sludge within 4 weeks.
This new biliary metal stent is easily inserted and does not shorten during stent release, allowing precise positioning. No acute complications occurred, but there were two cases of early stent dysfunction. The role of the JoStent SelfX in comparison with other biliary stents will need to be evaluated in a multicenter trial with a larger number of patients, to investigate the long-term results.
JoStent SelfX是一种新型的无覆膜自膨式镍钛合金胆道支架。与“金标准”Wallstent相比，该支架的主要优势在于支架释放过程中缩短程度极小（<10%）。开展了一项前瞻性可行性研究，以评估支架植入方法及其短期疗效。
2001年4月至2002年12月期间，对20例无法手术的恶性胆道梗阻患者植入了JoStent SelfX支架，主要病因是胰腺癌（20例中的12例）。所有患者在支架植入前均接受了括约肌切开术。植入后，在数天内检查了胆汁淤积和支架扩张的实验室参数。所有患者在植入后随访8周，以记录早期支架功能障碍情况。
所有患者的支架植入操作简便且成功，无技术问题。仅1例丝状狭窄患者需要预先进行探条扩张。支架释放过程中未观察到支架回缩。所有支架在5天内均完全展开。未发生急性并发症。观察到胆汁淤积的实验室参数升高情况得到了充分缓解。2例患者在4周内出现因胆管炎导致的复发性胆汁淤积和发热，或因胆泥导致支架闭塞。
这种新型胆道金属支架易于插入，在释放过程中不会缩短，便于精确定位。未发生急性并发症，但有2例早期支架功能障碍病例。与其他胆道支架相比，JoStent SelfX的作用需要在纳入更多患者的多中心试验中进行评估，以研究长期结果。
