Delineation of the extent of early gastric cancer by magnifying narrow-band imaging and chromoendoscopy: a multicenter randomized controlled trialTRIAL REGISTRATION: multicenter, randomized, controlled study UMIN000014628 at http://www.umin.ac.jp
submitted 23 March 2017
accepted after revision 19 December 2017
13 February 2018 (online)
Background Accurate delineation of tumor margins is necessary for curative resection of early gastric cancer (EGC). The objective of this multicenter, randomized, controlled study was to compare the accuracy with which magnifying narrow-band imaging (M-NBI) and indigo carmine chromoendoscopy delineate EGC margins.
Methods Patients with EGC ≥ 10 mm undergoing endoscopic or surgical resection were enrolled. The oral-side margins of the lesions were first evaluated with conventional white-light endoscopy in both groups and then delineated by either chromoendoscopy or M-NBI. Biopsies were taken from noncancerous and cancerous mucosa, each at 5 mm from the margin. Accurate delineation was judged to have been achieved when the histological findings in all biopsy samples were consistent with endoscopic diagnoses. The primary end point was the difference in rate of accurate delineation between the two techniques.
Results Data on 343 patients were analyzed. The accurate delineation rate (95 % confidence interval) was 85.7 % (80.4 – 91.0) in the chromoendoscopy group (n = 168), and 88.0 % (83.2 – 92.8) in the M-NBI group (n = 175; P = 0.63). Lower third tumor location (odds ratio [OR] 2.9; P = 0.01), nonflat macroscopic type (OR 4.4; P < 0.01), and high diagnostic confidence (OR 3.6; P < 0.001) were associated with accurate delineation, whereas use of M-NBI was not (OR 1.2; P = 0.39). Even after adjustment for identified confounders, the difference in accurate delineation between the groups was not significant (OR 1.0; P = 0.82).
Conclusions M-NBI does not offer superior delineation of EGC margins compared with chromoendoscopy; the two methods appear to be clinically equivalent.
- 1 Suzuki H, Oda I, Sekiguchi M. et al. Factors associated with incomplete gastric endoscopic submucosal dissection due to misdiagnosis. Endosc Int Open 2016; 25: 88-93
- 2 Kakushima N, Ono H, Tanaka M. et al. Factors related to lateral margin positivity for cancer in gastric specimens of endoscopic submucosal dissection. Dig Endosc 2011; 23: 227-232
- 3 Sekiguchi M, Suzuki H, Oda I. et al. Risk of recurrent gastric cancer after endoscopic resection with a positive lateral margin. Endoscopy 2014; 46: 273-278
- 4 Mashimoto A, Akazawa K, Isobe Y. et al. Gastric cancer treated in 2002 in Japan: 2009 annual report of the JGCA nationwide registry. Gastric Cancer 2013; 16: 1-27
- 5 Tsuda Y. A study in the diagnosis of gastric lesions using the fibergastroscope combined with a new staining process. Gastroenterological Endoscopy (Tokyo) 1967; 9: 189-195
- 6 Ida K, Hashimoto Y, Takeda S. et al. Endoscopic diagnosis of gastric cancer with dye scattering. Am J Gastroenterol 1975; 63: 316-320
- 7 Yao T, Fujiwara A, Watanabe H. et al. Endoscopic diagnosis of the extent of infiltration in gastric cancer (in Japanese with English abstract). Stomach and Intestine 1972; 7: 725-738
- 8 Nonaka K, Namoto M, Kitada H. et al. Usefulness of the DL in ME with NBI for determining the expanded area of early-stage differentiated gastric carcinoma. World J Gastrointest Endosc 2012; 4: 362-367
- 9 Nagahama T, Yao K, Maki S. et al. Useful of magnifying endoscopy with narrow-band imaging for determining the horizontal extent of early gastric cancer when there is an unclear margin by chromoendoscopy. Gastrointest Endosc 2011; 75: 1259-1267
- 10 Yao K, Oishi T. Microgastroscopic findings of mucosal microvascular architecture as visualized by magnifying endoscopy. Dig Endosc 2002; 13: 27-33
- 11 Yao K, Ohishi T, Matsui T. et al. Novel magnified endoscopic findings of microvascular architecture in intramucosal gastric cancer. Gastrointest Endosc 2002; 56: 279-284
- 12 Yao K, Anagnostopoulos GK, Ragunath K. Magnifying endoscopy for diagnosing and delineating early gastric cancer. Endoscopy 2009; 41: 462-467
- 13 Ezoe Y, Muto M, Uedo N. et al. Magnifying narrowband imaging is more accurate than conventional white-light imaging in diagnosis of gastric mucosal cancer. Gastroenterology 2011; 141: 2017-2025
- 14 Yao K, Yao T, Iwashita A. Determining the horizontal extent of early gastric carcinoma: two modern techniques based on differences in the mucosal microvascular architecture and density between carcinomatous and non-carcinomatous mucosa. Dig Endosc 2002; 14: 83-87
- 15 Nakayoshi T, Tajiri H, Matsuda K. et al. Magnifying endoscopy combined with narrow band imaging system for early gastric cancer: correlation of vascular pattern with histopathology. Endoscopy 2004; 36: 1080-1084
- 16 Kiyotoki S, Nishikawa J, Satake M. et al. Usefulness of magnifying endoscopy with narrow-band imaging for determining gastric tumor margin. J Gastroenterol Hepatol 2010; 25: 1636-1641
- 17 Uedo N, Fujishiro M, Goda K. et al. Role of narrow band imaging for diagnosis of early-stage esophagogastric cancer: current consensus of experienced endoscopists in Asia–Pacific region. Dig Endosc 2011; 23: 58-71
- 18 Bossuyt PM, Reitsma JB, Bruns DE. et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Clin Chem 2003; 49: 1-6
- 19 Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut 2002; 51: 130-131
- 20 Asada-Hirayama I, Kodashima S, Sakaguchi Y. et al. Magnifying endoscopy with narrow-band imaging is more accurate for determination of horizontal extent of early gastric cancers than chromoendoscopy. Endosc Int Open 2016; 4: 690-698
- 21 Ito M, Tanaka S, Takata S. et al. Morphological changes in human gastric tumours after eradication therapy of Helicobacter pylori in a short-term follow-up. Aliment Pharmacol Ther 2005; 21: 559-566
- 22 Kobayashi M, Hashimoto S, Nishikura K. et al. Magnifying narrow-band imaging of surface maturation in early differentiated-type gastric cancers after Helicobacter pylori eradication. J Gastroenterol 2013; 48: 1332-1342
- 23 Ono S, Kato M, Suzuki M. et al. Frequency of Helicobacter pylori-negative gastric cancer and gastric mucosal atrophy in a Japanese endoscopic submucosal dissection series including histological, endoscopic and serological atrophy. Digestion 2012; 86: 59-65
- 24 Matsuo T, Ito M, Tanaka S. et al. Low prevalence of Helicobacter pylori-negative gastric cancer among Japanese. Helicobacter 2011; 1: 415-419