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比较恶性结直肠梗阻支架的疗效:一项随机、前瞻性研究。

Comparison of efficacies between stents for malignant colorectal obstruction: a randomized, prospective study.

机构信息

Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Republic of Korea.

出版信息

Gastrointest Endosc. 2010 Aug;72(2):304-10. doi: 10.1016/j.gie.2010.02.046. Epub 2010 Jun 19.

Abstract

BACKGROUND

Colonoscopic insertion of a self-expandable metallic stent (SEMS) has been widely performed for the treatment of malignant colorectal obstruction. Different types of stents could influence the efficacy and complication rate of stent use.

OBJECTIVE

To compare the efficacy and complication rates between two SEMSs, the uncovered WallFlex stent and the covered Comvi stent.

DESIGN

A prospective, randomized study.

SETTING

Tertiary-care academic medical center.

PATIENTS

Between 2007 and 2009, a total of 151 patients with malignant colorectal obstruction were enrolled.

INTERVENTION

Two types of colorectal SEMSs (the uncovered WallFlex stent by Boston Scientific Corp and the newly developed covered Comvi stent by Taewoong Medical Co) were inserted.

MAIN OUTCOME MEASUREMENTS

Technical success, clinical success, stent patency, and complication rate according to stent type.

RESULTS

Technical failure occurred in 2 patients (1.3%); one was in the WallFlex group and the other in the Comvi group. Clinical failure developed in 9 patients (6.0%): 6 patients from the WallFlex group and 3 from the Comvi group. Complications because of cancer infiltration occurred more frequently in the WallFlex group (14.5% vs 3.8%). However, the rate of stent migration was higher in the Comvi group (21.1% vs 1.8%). The mean patency of the stent did not differ between the two groups (P = .50).

LIMITATIONS

This was a single-center study.

CONCLUSION

Both uncovered WallFlex and covered Comvi stents were suitable for relieving malignant colorectal obstruction. Tumor ingrowth was more common in the WallFlex group, but stent migration was more common in the Comvi group.

摘要

背景

经内镜置入自膨式金属支架(SEMS)已广泛应用于治疗恶性结直肠梗阻。不同类型的支架可能会影响支架使用的疗效和并发症发生率。

目的

比较两种 SEMS(Boston Scientific 公司的 uncovered WallFlex 支架和 Taewoong Medical 公司的新型 covered Comvi 支架)的疗效和并发症发生率。

设计

前瞻性、随机研究。

设置

三级医疗中心。

患者

2007 年至 2009 年期间,共纳入 151 例恶性结直肠梗阻患者。

干预措施

置入两种结直肠 SEMS(Boston Scientific 公司的 uncovered WallFlex 支架和 Taewoong Medical 公司的新型 covered Comvi 支架)。

主要观察指标

根据支架类型评估技术成功率、临床成功率、支架通畅率和并发症发生率。

结果

2 例(1.3%)患者出现技术失败,1 例发生于 WallFlex 组,另 1 例发生于 Comvi 组。9 例(6.0%)患者出现临床失败:6 例来自 WallFlex 组,3 例来自 Comvi 组。因癌症浸润导致的并发症在 WallFlex 组更为常见(14.5%比 3.8%)。然而,支架迁移的发生率在 Comvi 组更高(21.1%比 1.8%)。两组支架通畅时间的平均值无差异(P =.50)。

局限性

这是一项单中心研究。

结论

uncovered WallFlex 和 covered Comvi 支架均适用于缓解恶性结直肠梗阻。肿瘤向支架内生长在 WallFlex 组更为常见,但支架迁移在 Comvi 组更为常见。

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