Background <p>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 <i>Helicobacter pylori</i> eradication.</p> Methods <p>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 <i>H. pylori</i> infection status.</p> Results <p>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 (&lt; 10&#xa0;mm/ ≥ 10&#xa0;mm); sensitivity 65.7%/76.9%, specificity 88.6%/88.9%; (4) <i>H. pylori</i> infection status (uninfected/previously infected/currently infected); sensitivity 50.0%/71.0%/86.7%, specificity 91.3%/88.2%/88.9%.</p> Conclusions <p>The diagnostic performance of ME with 3G-NBI for EGC was acceptable, primarily in patients with <i>H. pylori</i> eradication.</p> Trial Registration: <p>This trial was registered in jRCT (Identifier jRCT1032210213).</p>

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Diagnostic performance of magnifying endoscopy with third-generation narrow-band imaging for early gastric cancer: post hoc analysis of a randomized trial (3G detection trial)

  • Nobuhisa Minakata,
  • Tomohiro Kadota,
  • Seiichiro Abe,
  • Noriya Uedo,
  • Hisashi Doyama,
  • Yasuaki Furue,
  • Akira Yokoyama,
  • Satoru Nonaka,
  • Yasuhiro Tani,
  • Naohiro Yoshida,
  • Chikatoshi Katada,
  • Manabu Muto,
  • Takashi Ikeno,
  • Masashi Wakabayashi,
  • Tomonori Yano

摘要

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).