Division of Gastroenterology, Tohoku University Graduate School of Medicine, Miyagi, Japan.
Department of Gastroenterology and Neurology, Akita University Graduate School of Medicine, Akita, Japan.
Dig Endosc. 2023 Nov;35(7):835-844. doi: 10.1111/den.14538. Epub 2023 Mar 28.
Blue light imaging (BLI) and linked color imaging (LCI) are superior to conventional white light imaging for detecting esophageal squamous cell carcinoma (ESCC). Hence, we compared their diagnostic performances in ESCC screening.
This open-labeled, randomized controlled trial was performed at seven hospitals. Patients with a high risk of ESCC were randomly assigned to the BLI group (BLI followed by LCI) and LCI group (LCI followed by BLI). The primary end-point was the detection rate of ESCC in the primary mode. The main secondary end-point was its miss rate in the primary mode.
In total, 699 patients were enrolled. The detection rate of ESCC did not significantly differ between the BLI and LCI groups (4.0% [14/351] vs. 4.9% [17/348]; P = 0.565); however, the number of patients with ESCC tended to be smaller in the BLI group (19 vs. 30). Notably, the miss rate of ESCC was lower in the BLI group (26.3% [5/19] vs. 63.3% [19/30]; P = 0.012) and LCI detected no ESCCs missed by BLI. The sensitivity was higher in BLI (75.0% vs. 47.6%; P = 0.042); on the other hand, the positive predictive value in BLI tended to be lower (28.8% vs. 45.5%; P = 0.092).
The detection rates of ESCC did not significantly differ between BLI and LCI. Although BLI may have the potential to be advantageous over LCI for the diagnosis of ESCC, it is still unclear whether BLI is superior to LCI, and a further large-scale study is needed.
Japan Registry of Clinical Trials (jRCT1022190018-1).
蓝光成像（BLI）和关联色成像（LCI）在检测食管鳞状细胞癌（ESCC）方面优于传统白光成像。因此，我们比较了它们在 ESCC 筛查中的诊断性能。
这是一项在七家医院进行的开放标签、随机对照试验。高危 ESCC 患者被随机分配到 BLI 组（BLI 后行 LCI）和 LCI 组（LCI 后行 BLI）。主要终点是初始模式下 ESCC 的检出率。主要次要终点是初始模式下的漏诊率。
共纳入 699 例患者。BLI 组和 LCI 组 ESCC 的检出率无显著差异（4.0%[14/351] vs. 4.9%[17/348]；P=0.565）；然而，BLI 组 ESCC 患者数量较少（19 例 vs. 30 例）。值得注意的是，BLI 组 ESCC 的漏诊率较低（26.3%[5/19] vs. 63.3%[19/30]；P=0.012），LCI 未检测到 BLI 漏诊的 ESCC。BLI 的灵敏度较高（75.0% vs. 47.6%；P=0.042）；另一方面，BLI 的阳性预测值较低（28.8% vs. 45.5%；P=0.092）。
BLI 和 LCI 检测 ESCC 的检出率无显著差异。尽管 BLI 在 ESCC 诊断方面可能优于 LCI，但尚不清楚 BLI 是否优于 LCI，仍需进一步的大规模研究。
日本临床试验注册中心（jRCT1022190018-1）。
