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内镜治疗恶性胃和十二指肠狭窄:一项前瞻性、多中心研究。

Endoscopic treatment of malignant gastric and duodenal strictures: a prospective, multicenter study.

机构信息

Digestive Endoscopy Unit, Catholic University, Rome, Italy.

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

出版信息

Gastrointest Endosc. 2014 Jan;79(1):66-75. doi: 10.1016/j.gie.2013.06.032. Epub 2013 Aug 6.

Abstract

BACKGROUND

Malignant gastric outlet obstruction is often treated by stent placement.

OBJECTIVE

To investigate the outcomes of stent placement in the palliative treatment of malignant neoplasms.

DESIGN

Prospective, observational, multicenter registry.

SETTING

Six tertiary care centers in 5 countries.

PATIENTS

A total of 108 adult patients with malignant gastric outlet obstruction.

INTERVENTIONS

Placement of an uncovered, self-expandable, metal duodenal stent.

MAIN OUTCOME MEASUREMENTS

The primary endpoint was stent patency at 14 days after stent implantation. Secondary endpoints included stent patency at 1, 2, 3, and 6 months, gastric outlet obstruction scoring system (GOOSS) scores at 14 days and 1, 2, 3, and 6 months after stent deployment, technical success, adverse events, and patient survival (ie, confirmed duration of the implant).

RESULTS

Technical success was achieved in 99.1% of stent placements. Stent patency at 14 days was 94.6%. Kaplan-Meier estimates of stent patency were 92.9% at 1 month, 86.2% at 2 months, 81.9% at 3 months, and 63.4% at 6 months. At 14 days, GOOSS scores increased by a median of 1 point. The overall GI adverse event rate was 32.4%; however, the stent-related adverse event rate was 19.4%. The median implant duration was 47 days (range 0-195 days).

LIMITATIONS

Observational study, no control group.

CONCLUSIONS

Duodenal stent placement resulted in prompt relief of malignant gastric outlet obstruction and improved GOOSS scores. (

CLINICAL TRIAL REGISTRATION NUMBER

NCT00991614.).

摘要

背景

恶性胃出口梗阻常采用支架置入治疗。

目的

研究支架置入术在恶性肿瘤姑息治疗中的疗效。

设计

前瞻性、观察性、多中心登记研究。

地点

5 个国家的 6 家三级医疗中心。

患者

108 例恶性胃出口梗阻成年患者。

干预

放置无覆盖、自膨式金属十二指肠支架。

主要观察终点

支架植入后 14 天的通畅率。次要终点包括支架植入后 1、2、3 和 6 个月的通畅率、胃出口梗阻评分系统(GOOSS)评分(支架植入后 14 天和 1、2、3 和 6 个月)、技术成功率、不良事件和患者生存(即植入物的确认持续时间)。

结果

支架置入成功率为 99.1%。支架植入后 14 天的通畅率为 94.6%。支架通畅率的 Kaplan-Meier 估计值分别为 1 个月时为 92.9%,2 个月时为 86.2%,3 个月时为 81.9%,6 个月时为 63.4%。支架植入后 14 天,GOOSS 评分中位数增加 1 分。总的胃肠道不良事件发生率为 32.4%;然而,支架相关不良事件发生率为 19.4%。植入物的中位持续时间为 47 天(0-195 天)。

局限性

观察性研究,无对照组。

结论

十二指肠支架置入术可迅速缓解恶性胃出口梗阻,改善 GOOSS 评分。(临床试验注册号:NCT00991614.)。

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