Effect of an Endoscopy Screening on Upper Gastrointestinal Cancer Mortality: A Community-Based Multicenter Cluster Randomized Clinical Trial.

We aimed to quantify the effect of endoscopy screening.

我们的目标是量化内镜筛查的效果。

Methods

This is a community-based, multicenter, cluster randomized clinical trial conducted in both high-risk and non-high-risk areas of China.

这是一项在中国高风险和非高风险地区进行的基于社区的多中心群组随机临床试验。

Randomization and recruitment occurred between 2015 and 2017, with follow-up conducted until 2022.

随机分组和招募工作发生在2015年至2017年之间，随访工作一直持续到2022年。

The intervention was an invitation to receive endoscopic screening, as opposed to receiving usual care (unscreened).

该干预措施是邀请接受内镜筛查，与接受常规护理（未筛查）相对。

In non-high-risk areas, only participants assessed as high-risk by risk scores in the screening group were invited for endoscopic screening.

在非高风险区域，只有在筛查组中被风险评分评估为高风险的参与者才被邀请进行内镜筛查。

The primary outcome was the cumulative risk of death from upper gastrointestinal cancer, adjusted for baseline characteristics and cluster effects.

主要结果是上消化道癌症死亡的累积风险，根据基线特征和群集效应进行了调整。

Results

A total of 234,635 participants were included in the intention-to-screen analysis, with a median age of 52 years.

共有234,635名参与者被纳入意向筛查分析，中位年龄为52岁。

In high-risk areas, 64,836 individuals from 81 clusters were randomized to the screening group, and 59,379 individuals from 82 clusters were randomized to the control group.

在高风险区域，从81个群集中随机选取了64,836名个体进入筛查组，从82个群集中随机选取了59,379名个体进入对照组。

In non-high-risk areas, 58,367 individuals from 92 clusters were randomized to the screening group, 52,053 individuals from 90 clusters were randomized to the control group.

在非高风险区域，从92个群集中随机选取了58,367名个体进入筛查组，从90个群集中随机选取了52,053名个体进入对照组。

Among high-risk areas, 480 (adjusted cumulative risk, 0.77%) died due to upper gastrointestinal cancers within 7.5 years in the screening group vs 545 (0.99%) deaths in the control group (risk ratio, 0.78; 95% confidence interval, 0.66-0.91).

在高风险地区，7.5年内筛查组有480人（调整后的累积风险为0.77%）因上消化道癌症死亡，而对照组有545人（0.99%）死亡（风险比为0.78；95%置信区间为0.66-0.91）。

Among non-high-risk areas, adjusted risk was 0.26% (146 deaths) in the screening group and 0.30% (149 deaths) in the control group (risk ratio, 0.86; 95% confidence interval, 0.65-1.13).

在非高风险地区，筛查组的调整风险为0.26%（146例死亡），对照组为0.30%（149例死亡）（风险比为0.86；95%置信区间为0.65-1.13）。

Conclusions

An invitation to endoscopic screening reduced upper gastrointestinal cancer mortality in high-risk areas.

邀请进行内镜筛查在高风险地区降低了上消化道癌症的死亡率。

In non-high-risk areas, an invitation to endoscopic screening based on risk scores did not significantly decrease upper gastrointestinal cancer deaths, but longer follow-up time was required.

在非高风险地区，基于风险评分的内镜筛查邀请并未显著降低上消化道癌症的死亡率，但需要更长时间的随访。

(Chinese Clinical Trial Registry Identifier: ChiCTR-EOR-16008577.).

（中国临床试验注册中心注册标识：ChiCTR-EOR-16008577。）