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外科胃空肠吻合术或内镜支架置入术缓解恶性胃出口梗阻(SUSTENT 研究):一项多中心随机试验。

Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial.

机构信息

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

出版信息

Gastrointest Endosc. 2010 Mar;71(3):490-9. doi: 10.1016/j.gie.2009.09.042. Epub 2009 Dec 8.

Abstract

BACKGROUND

Both gastrojejunostomy (GJJ) and stent placement are commonly used palliative treatments of obstructive symptoms caused by malignant gastric outlet obstruction (GOO).

OBJECTIVE

Compare GJJ and stent placement.

DESIGN

Multicenter, randomized trial.

SETTING

Twenty-one centers in The Netherlands.

PATIENTS

Patients with GOO.

INTERVENTIONS

GJJ and stent placement.

MAIN OUTCOME MEASUREMENTS

Outcomes were medical effects, quality of life, and costs. Analysis was by intent to treat.

RESULTS

Eighteen patients were randomized to GJJ and 21 to stent placement. Food intake improved more rapidly after stent placement than after GJJ (GOO Scoring System score > or = 2: median 5 vs 8 days, respectively; P < .01) but long-term relief was better after GJJ, with more patients living more days with a GOO Scoring System score of 2 or more than after stent placement (72 vs 50 days, respectively; P = .05). More major complications (stent: 6 in 4 patients vs GJJ: 0; P = .02), recurrent obstructive symptoms (stent: 8 in 5 patients vs GJJ: 1 in 1 patient; P = .02), and reinterventions (stent: 10 in 7 patients vs GJJ: 2 in 2 patients; P < .01) were observed after stent placement compared with GJJ. When stent obstruction was not regarded as a major complication, no differences in complications were found (P = .4). There were also no differences in median survival (stent: 56 days vs GJJ: 78 days) and quality of life. Mean total costs of GJJ were higher compared with stent placement ($16,535 vs $11,720, respectively; P = .049 [comparing medians]). Because of the small study population, only initial hospital costs would have been statistically significant if the Bonferroni correction for multiple testing had been applied.

LIMITATIONS

Relatively small patient population.

CONCLUSIONS

Despite slow initial symptom improvement, GJJ was associated with better long-term results and is therefore the treatment of choice in patients with a life expectancy of 2 months or longer. Because stent placement was associated with better short-term outcomes, this treatment is preferable for patients expected to live less than 2 months. (

CLINICAL TRIAL REGISTRATION NUMBER

ISRCTN 06702358.).

摘要

背景

胃空肠吻合术(GJJ)和支架放置均是治疗恶性胃出口梗阻(GOO)引起的梗阻症状的常用姑息疗法。

目的

比较 GJJ 和支架放置。

设计

多中心、随机试验。

地点

荷兰 21 个中心。

患者

GOO 患者。

干预措施

GJJ 和支架放置。

主要观察指标

观察结果为医疗效果、生活质量和成本。分析采用意向治疗。

结果

18 例患者随机分为 GJJ 组,21 例患者分为支架组。支架组的食物摄入改善速度快于 GJJ 组(GOO 评分系统评分≥2:中位 5 天与 8 天,P<0.01),但 GJJ 组的长期缓解效果更好,有更多患者(分别为 72 天和 50 天)的 GOO 评分系统评分≥2(P=0.05)。支架组发生更多主要并发症(4 例患者中的 6 例与 GJJ 组中的 0 例;P=0.02)、复发性梗阻症状(5 例患者中的 8 例与 1 例患者中的 GJJ 组;P=0.02)和再介入治疗(7 例患者中的 10 例与 2 例患者中的 GJJ 组;P<0.01)。与 GJJ 组相比,支架组支架阻塞未被视为主要并发症时,两组间的并发症差异无统计学意义(P=0.4)。两组中位生存时间(支架组:56 天与 GJJ 组:78 天)和生活质量也无差异。GJJ 的总平均成本高于支架组(分别为 16535 美元与 11720 美元,P=0.049[中位数比较])。由于研究人群较小,如果应用 Bonferroni 多重检验校正,初始住院费用将具有统计学意义。

局限性

患者人群相对较小。

结论

尽管初始症状改善缓慢,但 GJJ 与更好的长期结果相关,因此是预期生存时间为 2 个月或更长时间的患者的首选治疗方法。由于支架放置与更好的短期结果相关,因此对于预期生存时间少于 2 个月的患者,这种治疗方法更为可取。(临床试验注册号:ISRCTN 06702358。)

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