Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial.

We aimed to assess whether the use of EUS-GE with a double balloon occluder for malignant gastric outlet obstruction could reduce the need for reintervention within 6 months compared with conventional duodenal stenting.

我们旨在评估使用带有双球囊封堵器的EUS-GE治疗恶性胃出口梗阻，是否能在6个月内减少再次干预的需求，与传统的十二指肠支架置入相比。

Methods

The was an international, multicentre, randomised, controlled trial conducted at seven sites in Hong Kong, Belgium, Brazil, India, Italy, and Spain.

这是一项在比利时、巴西、印度、意大利和西班牙的香港七个地点进行的国际多中心随机对照试验。

Consecutive patients (aged ≥18 years) with malignant gastric outlet obstruction due to unresectable primary gastroduodenal or pancreatobiliary malignancies, a gastric outlet obstruction score (GOOS) of 0 (indicating an inability to intake food or liquids orally), and an Eastern Cooperative Oncology Group performance status score of 3 or lower were included and randomly allocated (1:1) to receive either EUS-GE or duodenal stenting.

连续的患者（年龄≥18岁）因无法切除的原发性胃十二指肠或胰胆恶性肿瘤导致的恶性胃出口梗阻，胃出口梗阻评分（GOOS）为0（表明无法口服食物或液体），以及东部肿瘤协作组表现状态评分3分或以下，被纳入并随机分配（1:1），接受EUS-GE或十二指肠支架置入术。

The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring additional endoscopic intervention due to stent dysfunction (ie, restenosis of the stent due to tumour ingrowth, tumour overgrowth, or food residue; stent migration; or stent fracture) within 6 months, analysed in the intention-to-treatpopulation.

主要结果是6个月内的再次干预率，定义为在6个月内因支架功能障碍（即由于肿瘤内生长、肿瘤过度生长或食物残留导致的支架再狭窄；支架移位；或支架断裂）而需要额外内镜干预的患者百分比，在意向治疗人群中进行分析。

Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in gastric outlet obstruction score [GOOS] within 3 days), adverse events within 30 days, death within 30 days, duration of stent patency, GOOS at 1 month, and quality-of-life scores.

预先设定的次要结果包括技术成功（支架成功放置）、临床成功（3天内胃出口梗阻评分[GOOS]提高1分）、30天内的不良事件、30天内的死亡率、支架通畅时间、1个月时的GOOS以及生活质量评分。

This study is registered with ClinicalTrials.gov (NCT03823690) and is completed.

本研究已在ClinicalTrials.gov注册（NCT03823690），研究已完成。

Results

Between Dec 1, 2020, and Feb 28, 2022, 185 patients were screened and 97 (46 men and 51 women) were recruited and randomly allocated (48 to the EUS-GE group and 49 to the duodenal stent group).

在2020年12月1日至2022年2月28日期间，共有185名患者接受了筛查，最终97名患者（46名男性和51名女性）被招募并随机分配（48人进入内镜超声引导下胃空肠吻合术（EUS-GE）组，49人进入十二指肠支架组）。

Mean age was 69·5 years (SD 12·6) in the EUS-GE group and 64·8 years (13·0) in the duodenal stent group.

EUS-GE组的平均年龄为69.5岁（标准差12.6），十二指肠支架组的平均年龄为64.8岁（标准差13.0）。

All randomly allocated patients completed follow-up and were analysed.

所有随机分配的患者均完成了随访并进行了分析。

Reintervention within 6 months was required in two (4%) patients in the EUS-GE group and 14 (29%) in the duodenal stent group [p=0·0020; risk ratio 0·15 [95% CI 0·04-0·61]).

在EUS-GE组中，有两名（4%）患者在6个月内需要再次干预，而在十二指肠支架组中有14名（29%）患者需要再次干预[p=0·0020; 风险比0·15 [95% 置信区间 0·04-0·61]。

No significant difference in duration of stent patency was noted between groups. 1-month GOOS was significantly better in the EUS-GE group (mean 2·41 [SD 0·7]) than the duodenal stent group (1·91 [0·9], p=0·012).

两组之间的支架通畅持续时间没有显著差异。1个月时，EUS-GE组的GOOS评分显著高于十二指肠支架组（平均值2·41 [标准差0·7] 对比 1·91 [0·9]，p=0·012）。

There were no statistically significant differences between the EUS-GE and duodenal stent groups in death within 30 days (ten [21%] vs six [12%] patients, respectively, p=0·286), technical success, clinical success, or quality-of-life scores at 1 month.

在30天内死亡的患者中，内镜超声引导胃空肠吻合术(EUS-GE)组与十二指肠支架组之间没有统计学上的显著差异（分别有10名[21%]和6名[12%]患者，p=0·286），技术成功率、临床成功率或1个月的生活质量评分也没有差异。

Adverse events occurred 11 (23%) patients in the EUS-GE group and 12 (24%) in the duodenal stent group within 30 days (p=1·00); three cases of pneumonia (two in the EUS-GE group and one in the duodenal stent group) were considered to be procedure related.

在30天内，EUS-GE组有11名（23%）患者和十二指肠支架组有12名（24%）患者发生了不良事件（p=1·00）；其中三例肺炎（EUS-GE组两例，十二指肠支架组一例）被认为是与手术相关的。

interpretation

In patients with malignant gastric outlet obstruction, EUS-GE can reduce the frequency of reintervention and result in better patient-reported eating habits compared with duodenal stenting although there was no significant difference in duration of stent patency or overall survivalbetween the two approaches.

在恶性胃出口梗阻患者中，与十二指肠支架植入术相比，内镜超声引导下胃空肠吻合术（EUS-GE）可以减少再次干预的频率，并改善患者报告的饮食习惯，尽管两种方法在支架通畅时间或总生存期上没有显著差异。

EUS-GE could be used preferentially over duodenal stending when expertise and required devices are available.

当具备专业知识和所需设备时，内镜超声引导下胃空肠吻合术（EUS-GE）可以优先于十二指肠支架植入术使用。

funding

Research Grants Council (Hong Kong Special Administrative Region, China) and Sociedad Española de Endoscopia Digestiva.

研究资助委员会（中国香港特别行政区）和西班牙消化内镜学会。