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一种用于预防移位的新型食管支架设计(镍钛记忆合金支架):42例患者的前瞻性研究。

A new esophageal stent design (Niti-S stent) for the prevention of migration: a prospective study in 42 patients.

作者信息

Verschuur Els M L, Homs Marjolein Y V, Steyerberg Ewout W, Haringsma Jelle, Wahab Peter J, Kuipers Ernst J, Siersema Peter D

机构信息

Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, The Netherlands.

出版信息

Gastrointest Endosc. 2006 Jan;63(1):134-40. doi: 10.1016/j.gie.2005.07.051.

DOI:10.1016/j.gie.2005.07.051
PMID:16377330
Abstract

BACKGROUND

Covered, rather than uncovered, metal stents are used for the palliation of dysphagia from esophageal cancer, but a major drawback is the risk of stent migration, which occurs in up to 20% of patients. To overcome this problem, a double-layered stent, the Niti-S stent (Taewong Medical, Seoul, Korea), has been developed. The Niti-S stent consists of an inner polyurethane layer to prevent tumor ingrowth and an outer uncovered nitinol wire tube to allow the mesh of the stent to embed itself in the esophageal wall.

METHODS

Between June 2003 and May 2004, 42 patients with malignant dysphagia caused by inoperable carcinoma of the esophagus or gastric cardia were treated with a Niti-S stent. Patients were prospectively followed and data collection focused on recurrent dysphagia, functional outcome, complications, and survival.

RESULTS

At 4 weeks, the dysphagia score had significantly improved from a median of 3 (liquids only) to 0 (ability to eat a normal diet). Five of 42 (12%) patients with a Niti-S stent developed recurrent dysphagia, mainly due to tissue overgrowth (2 of 42; 5%) and stent migration (3 of 42; 7%). Major complications (perforation, 1; aspiration pneumonia, 2; hemorrhage, 2) occurred in 5 of 42 (12%) patients. Pain following stent placement was observed in 5 of 42 (12%) patients, and symptomatic gastroesophageal reflux occurred in 2 of 42 (5%) patients.

CONCLUSIONS

The Niti-S stent provides symptomatic relief of malignant dysphagia and effectively reduces recurrent dysphagia. Its double-layered design is probably important in preventing migration. In addition, the complete covering of the Niti-S stent may be a factor in preventing tissue overgrowth at both ends of the stent.

摘要

背景

对于食管癌所致吞咽困难的姑息治疗,使用的是覆膜金属支架而非裸支架,但一个主要缺点是支架移位风险,高达20%的患者会发生这种情况。为克服这一问题,已研发出一种双层支架,即Niti - S支架(韩国首尔Taewong Medical公司生产)。Niti - S支架由内层聚氨酯层(防止肿瘤向内生长)和外层裸镍钛合金丝网管(使支架网孔嵌入食管壁)组成。

方法

2003年6月至2004年5月期间,42例因无法手术的食管癌或贲门癌导致恶性吞咽困难的患者接受了Niti - S支架治疗。对患者进行前瞻性随访,数据收集重点为复发性吞咽困难、功能结局、并发症和生存率。

结果

4周时,吞咽困难评分从中位数3(仅能吞咽液体)显著改善至0(能够正常饮食)。42例接受Niti - S支架治疗的患者中有5例(12%)出现复发性吞咽困难,主要原因是组织过度生长(42例中的2例;5%)和支架移位(42例中的3例;7%)。42例患者中有5例(12%)发生了严重并发症(穿孔1例、吸入性肺炎2例、出血2例)。42例患者中有5例(12%)在支架置入后出现疼痛,42例患者中有2例(5%)出现有症状的胃食管反流。

结论

Niti - S支架可缓解恶性吞咽困难症状,并有效减少复发性吞咽困难。其双层设计可能对防止移位很重要。此外,Niti - S支架的完全覆盖可能是防止支架两端组织过度生长的一个因素。

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