比较有效成像方式检测胃肿瘤：一项随机 3 臂 II 期试验。

Comparison of Effective Imaging Modalities for Detecting Gastric Neoplasms: A Randomized 3-Arm Phase II Trial.

机构信息

Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan.

Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.

出版信息

Am J Gastroenterol. 2024 Oct 1;119(10):2010-2018. doi: 10.14309/ajg.0000000000002871. Epub 2024 May 16.

DOI:10.14309/ajg.0000000000002871

PMID:38752623

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11446510/

Abstract

INTRODUCTION

The early detection of gastric neoplasms (GNs) leads to favorable treatment outcomes. The latest endoscopic system, EVIS X1, includes third-generation narrow-band imaging (3G-NBI), texture and color enhancement imaging (TXI), and high-definition white-light imaging (WLI). Therefore, this randomized phase II trial aimed to identify the most promising imaging modality for GN detection using 3G-NBI and TXI.

METHODS

Patients with scheduled surveillance endoscopy after a history of esophageal cancer or GN or preoperative endoscopy for known esophageal cancer or GN were randomly assigned to the 3G-NBI, TXI, or WLI groups. Endoscopic observations were performed to detect new GN lesions, and all suspected lesions were biopsied. The primary endpoint was the GN detection rate during primary observation. Secondary endpoints were the rate of missed GNs, early gastric cancer detection rate, and positive predictive value for a GN diagnosis. The decision rule had a higher GN detection rate between 3G-NBI and TXI, outperforming WLI by >1.0%.

RESULTS

Finally, 901 patients were enrolled and assigned to the 3G-NBI, TXI, and WLI groups (300, 300, and 301 patients, respectively). GN detection rates in the 3G-NBI, TXI, and WLI groups were 7.3, 5.0, and 5.6%, respectively. The rates of missed GNs were 1.0, 0.7, and 1.0%, the detection rates of early gastric cancer were 5.7, 4.0, and 5.6%, and the positive predictive values for the diagnosis of GN were 36.5, 21.3, and 36.8% in the 3G-NBI, TXI, and WLI groups, respectively.

DISCUSSION

Compared with TXI and WLI, 3G-NBI is a more promising modality for GN detection.

摘要

简介

早期发现胃肿瘤（GNs）可带来良好的治疗效果。最新的内镜系统 EVIS X1 包括第三代窄带成像（3G-NBI）、纹理和颜色增强成像（TXI）以及高清白光成像（WLI）。因此，本项随机 II 期试验旨在通过 3G-NBI 和 TXI 来确定最有前途的 GN 检测成像方式。

方法

患有食管癌或 GN 病史的患者或已知患有食管癌或 GN 的患者在术前接受内镜检查，这些患者被随机分配至 3G-NBI、TXI 或 WLI 组。进行内镜观察以检测新的 GN 病变，所有疑似病变均进行活检。主要终点是初次观察时的 GN 检出率。次要终点是 GN 漏诊率、早期胃癌检出率和 GN 诊断的阳性预测值。决策规则要求 3G-NBI 和 TXI 的 GN 检出率更高，优于 WLI 的幅度>1.0%。

结果

最终纳入 901 例患者，分别分配至 3G-NBI、TXI 和 WLI 组（每组 300、300 和 301 例）。3G-NBI、TXI 和 WLI 组的 GN 检出率分别为 7.3%、5.0%和 5.6%。GN 漏诊率分别为 1.0%、0.7%和 1.0%，早期胃癌检出率分别为 5.7%、4.0%和 5.6%，GN 诊断的阳性预测值分别为 36.5%、21.3%和 36.8%。