Generative AI-based low-dose digital subtraction angiography for intra-operative radiation dose reduction: a randomized controlled trial.

However, these procedures expose patients and healthcare providers to radiation, increasing the risk of health issues.

然而，这些手术程序使患者和医疗提供者暴露于辐射中，增加了健康问题的风险。

Despite many low-dose DSA imaging methods proposed, none have been prospectively clinically validated.

尽管提出了许多低剂量DSA成像方法，但没有一种方法经过前瞻性临床验证。

In this study, 46,829 patients (over 5 million DSA images) from 70 centers were used to iterate our previously developed generative artificial intelligence system (named GenDSA-V2).

在这项研究中，使用了来自70个中心的46,829名患者（超过500万张DSA图像）来迭代我们之前开发的生成式人工智能系统（命名为GenDSA-V2）。

A total of 1,068 patients (533 in intervention arm and 535 in control arm), with suspected cerebral aneurysms (n = 435), lung cancer (n = 417) or advanced liver cancer (n = 216), meeting surgical criteria, were enrolled to validate the GenDSA-V2.

共有1,068名患者（干预组533名，对照组535名），其中疑似脑动脉瘤患者435名，肺癌患者417名，晚期肝癌患者216名，均符合手术标准，被纳入以验证GenDSA-V2。

The primary outcome was radiation dose, while secondary outcomes included efficiency, operation time and intraoperative complications.

主要结果是辐射剂量，次要结果包括效率、手术时间和术中并发症。

Group assignments were blinded to patients, surgeons and investigators, while technicians were aware but not involved in data collection or analysis.

患者、外科医生和研究人员对分组情况不知情，而技术人员虽然知情但不参与数据收集或分析。

The GenDSA-V2 group showed substantially reduced radiation exposure, with an air kerma (AK) of 151.3 ± 125.1 mGy compared to 457.4 ± 407.4 mGy in the standard clinical protocols (SCP) group (mean difference = -306.1 mGy, 95% confidence interval(CI) = -342.3 to -269.9, P < 0.001 for superiority) and a dose-area product (DAP) of 4009.7 ± 2767.9 μGy m2 versus 12531.6 ± 9145.9 μGy m2 (mean difference = -8521.9 μGy m2, 95% CI = -9333.1 to -7710.7, P < 0.001 for superiority).

GenDSA-V2组显示出显著降低的辐射暴露，空气比释动能（AK）为151.3 ± 125.1 mGy，与标准临床协议（SCP）组的457.4 ± 407.4 mGy相比（平均差异 = -306.1 mGy，95%置信区间（CI）= -342.3至-269.9，P < 0.001，显示优越性），剂量面积乘积（DAP）为4009.7 ± 2767.9 μGy m2，与12531.6 ± 9145.9 μGy m2相比（平均差异 = -8521.9 μGy m2，95% CI = -9333.1至-7710.7，P < 0.001，显示优越性）。

Mean operation time was 33.1 ± 10.8 min in the SCP group and 34.8 ± 11.8 min in the GenDSA-V2 group (mean difference = 1.7 min, 95% CI = 0.3 to 3.1, P < 0.001 for noninferiority).

SCP组的平均手术时间为33.1±10.8分钟，GenDSA-V2组为34.8±11.8分钟（平均差异=1.7分钟，95%置信区间=0.3至3.1，P<0.001，显示非劣效性）。

Complication rates were similar (SCP = 8.1%, GenDSA-V2 = 7.5%, mean difference = -0.6%, 95% CI = -3.8% to 2.6%, P < 0.001 for noninferiority).

并发症发生率相似（SCP组为8.1%，GenDSA-V2组为7.5%，平均差异=-0.6%，95%置信区间=-3.8%至2.6%，P<0.001，显示非劣效性）。

The GenDSA system reduces radiation exposure to both physicians and patients by approximately two-thirds during DSA-guided procedures, demonstrating substantial clinical and translational value.

GenDSA系统在DSA引导的手术过程中，将医生和患者的辐射暴露量减少了大约三分之二，显示出显著的临床和转化价值。

Chinese Clinical Trial Registry: ChiCTR2400084789 .

中国临床试验注册中心：ChiCTR2400084789。