Nobuhisa Minakata, Tomohiro Kadota, Seiichiro Abe, Noriya Uedo, Hisashi Doyama, Yasuaki Furue, Akira Yokoyama, Satoru Nonaka, Yasuhiro Tani, Naohiro Yoshida, Chikatoshi Katada, Manabu Muto, T Ikeno, Masashi Wakabayashi, Tomonori Yano
BACKGROUND: In this study, we investigated the diagnostic performance of magnifying endoscopy (ME) with third-generation narrow-band imaging (3G-NBI) for early gastric cancer (EGC), primarily in patients with Helicobacter pylori eradication. METHODS: This was a post hoc analysis of a multicenter, randomized trial comparing 3G-NBI, texture and color enhancement imaging, and white-light imaging in gastric neoplasm (GN) detection. For all detected lesions, the endoscopic diagnosis of ME using 3G-NBI was compared with the pathological diagnosis. The primary analyses focused on the sensitivity and specificity of ME with 3G-NBI for EGC or non-EGC. The diagnostic performance was analyzed according to confidence level, macroscopic type, lesion size, and H. pylori infection status. RESULTS: This study included 901 patients; 228 suspected GN lesions in 187 patients were analyzed. The lesions were diagnosed with EGC in 62 (27 with high confidence) and non-EGC in 166 (91 with high confidence) patients using ME with 3G-NBI and pathologically diagnosed as EGC in 61 and non-EGC in 167 patients. The overall diagnostic performance was sensitivity and specificity of 70.5% and 88.6%, respectively. The diagnostic performance of each category was as follows: (1) confidence level (high/low); sensitivity 78.1%/62.1%, specificity 97.7%/79.0%; (2) macroscopic type (elevated/flat or depressed); sensitivity 84.6%/66.7%, specificity 96.7%/86.9%; (3) lesion diameter (< 10 mm/ ≥ 10 mm); sensitivity 65.7%/76.9%, specificity 88.6%/88.9%; (4) H. pylori infection status (uninfected/previously infected/currently infected); sensitivity 50.0%/71.0%/86.7%, specificity 91.3%/88.2%/88.9%. CONCLUSIONS: The diagnostic performance of ME with 3G-NBI for EGC was acceptable, primarily in patients with H. pylori eradication. TRIAL REGISTRATION: This trial was registered in jRCT (Identifier jRCT1032210213).