Endoscopic or surgical gastroenterostomy for malignant gastric outlet obstruction: a randomised trial.

We compared both methods to determine whether clinical outcomes for EUS-GE are superior to surgery.

我们比较了这两种方法，以确定EUS-GE的临床结果是否优于手术。

Methods

We conducted a multicentre, randomised superiority trial of patients with malignant GOO to receive either EUS-GE or SGJ.

我们开展了一项多中心、随机优效试验，针对患有恶性胃出口梗阻（GOO）的患者，他们接受内镜超声引导下胃空肠吻合术（EUS-GE）或胃空肠吻合术（SGJ）治疗。

Primary endpoint was composite measure, consisting of Gastric Outlet Obstruction Scoring System (GOOSS) score of 0 or 1 at hospital discharge, need for reinterventions or supplemental nutrition, or procedure-related adverse events during 6-month follow-up or until death.

主要终点是一个综合指标，包括住院期间胃出口梗阻评分系统（GOOSS）评分为0或1，需要再次干预或补充营养，或在6个月随访期间或直至死亡期间出现与手术相关的不良事件。

Secondary endpoints were time to solid diet, length of hospitalisation, health-related quality of life (HRQoL) and treatment costs.

次要终点包括固体饮食恢复时间、住院时长、健康相关生活质量（HRQoL）和治疗成本。

Results

74 patients were randomly assigned to EUS-GE (38 patients) or SGJ (36 patients).

74名患者被随机分配至内镜超声引导下胃空肠吻合术（EUS-GE，38名患者）或胃空肠造口术（SGJ，36名患者）。

Primary endpoint occurred in 7.9% of patients who received EUS-GE and 38.9% in SGJ (risk difference -31.0%, 95% CI -47.6% to -11.4%, p=0.002).

主要终点事件在7.9%接受内镜超声引导下胃空肠吻合术(EUS-GE)的患者和38.9%接受经皮胃空肠吻合术(SGJ)的患者中发生（风险差异-31.0%，95%置信区间-47.6%至-11.4%，p=0.002）。

EUS-GE was associated with more rapid advancement to solid diet (median 2 days (P25-P75, 2-3) vs 5 days (P25-P75, 3.5-9)), shorter hospitalisation (median 3 days (P25-P75, 3-6) vs 9 days (P25-P75, 6-12.5)), better HRQoL for physical (p=0.0016) and social functioning (p=0.011) and lower treatment costs (US$33 934 vs US$51 437, difference -US$17 503 (95% CI -US$27 807 to -US$7920)).

EUS-GE与更快的固体饮食恢复相关（中位数2天（四分位数间距，2-3）vs 5天（四分位数间距，3.5-9）），较短的住院时间（中位数3天（四分位数间距，3-6）vs 9天（四分位数间距，6-12.5）），更好的身体健康和社交功能的健康相关生活质量（HRQoL）（p=0.0016和p=0.011），以及较低的治疗费用（US$33 934 vs US$51 437，差异-US$17 503（95%置信区间-US$27 807至-US$7920））。

Conclusions

In this randomised trial, EUS-GE was superior to SGJ with regards to oral intake, need for reinterventions or supplemental nutrition, length of hospitalisation, quality of life and treatment costs.

在这项随机试验中，与SGJ相比，EUS-GE在口服摄入、需要再次干预或补充营养、住院时间、生活质量以及治疗成本方面表现更优。

trial_registration_number

NCT05548114.

NCT05548114。