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一种新型带控释系统的金属支架用于恶性吞咽困难的姑息治疗:前瞻性、多中心研究。

A new metal stent with a controlled-release system for palliation of malignant dysphagia: a prospective, multicenter study.

机构信息

Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.

出版信息

Gastrointest Endosc. 2010 Mar;71(3):455-60. doi: 10.1016/j.gie.2009.09.046. Epub 2009 Dec 8.

DOI:10.1016/j.gie.2009.09.046
PMID:20003967
Abstract

BACKGROUND

Self-expanding metal stents are frequently used for the palliation of malignant dysphagia. Recently, a new stent design, the Evolution stent (Cook Medical, Limerick, Ireland), was developed. The stent has an internal and external silicone coating to resist tissue ingrowth and uncoated dual flanges on both ends to prevent migration. Its controlled-release system may allow full control and precise positioning of the stent.

OBJECTIVE

To determine the safety and clinical effectiveness of the Evolution stent for the palliation of dysphagia in patients with malignant strictures located in the esophagus (n = 33 [75%]) or gastric cardia (n = 11 [25%]).

METHODS

All patients who underwent placement of an esophageal Evolution stent from February to December 2008 received follow-up telephone calls 14 days after treatment and thereafter monthly until death. Data on technical and clinical outcome, complications, and recurrent dysphagia were collected.

RESULTS

A total of 44 patients (32 [73%] men, median age 74 years [range 48-91 years]) were treated with the Evolution stent. The median tumor length was 6 cm (range 1-11 cm). Stent placement was technically successful in 41 patients. Dysphagia improved from a median of 3 (ability to swallow liquids only) to 1 (ability to eat some solid foods) 4 weeks after stent placement. Major complications occurred in 4 (9%) patients, ie, pneumonia (3 patients) and hemorrhage (1 patient). Two (5%) patients died of pneumonia. Minor complications included gastroesophageal reflux and mild retrosternal pain in 11 (25%) and 4 (9%) patients, respectively. Recurrent dysphagia developed in 11 (25%) patients as a result of tissue ingrowth or overgrowth (6 patients; 14%), food impaction (3 patients; 7%), or stent migration (2 patients; 5%).

CONCLUSIONS

The Evolution stent is safe and effective for the palliation of dysphagia from esophageal and gastric cardia cancer. Randomized trials are needed to compare this device with other stent designs.

摘要

背景

自膨式金属支架常用于缓解恶性吞咽困难。最近,一种新的支架设计,Evolution 支架(库克爱尔兰有限公司,利默里克)被开发出来。该支架有内外硅胶涂层以防止组织向内生长,两端无涂层的双翼以防止迁移。其控释系统可以实现对支架的完全控制和精确定位。

目的

确定 Evolution 支架治疗食管(n = 33 [75%])或胃贲门(n = 11 [25%])恶性狭窄引起的吞咽困难的安全性和临床疗效。

方法

所有于 2008 年 2 月至 12 月期间接受食管 Evolution 支架置入术的患者,在治疗后 14 天及以后每月进行一次随访电话,并在死亡前持续进行。收集技术和临床结果、并发症和复发性吞咽困难的数据。

结果

共 44 例患者(32 例[73%]为男性,中位年龄为 74 岁[范围为 48-91 岁])接受了 Evolution 支架治疗。肿瘤长度中位数为 6cm(范围为 1-11cm)。41 例患者支架置入技术成功。支架置入后 4 周,吞咽困难从中位数 3 级(仅能吞咽液体)改善至 1 级(能吃一些固体食物)。4 例(9%)患者发生严重并发症,即肺炎(3 例)和出血(1 例)。2 例(5%)患者因肺炎死亡。轻微并发症包括胃食管反流和轻度胸骨后疼痛,分别为 11 例(25%)和 4 例(9%)。11 例(25%)患者因组织向内生长或过度生长(6 例;14%)、食物嵌塞(3 例;7%)或支架迁移(2 例;5%)而出现复发性吞咽困难。

结论

Evolution 支架治疗食管和胃贲门癌引起的吞咽困难是安全有效的。需要进行随机试验来比较该设备与其他支架设计。

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