Early gastric cancer detection in high-risk patients: a multicentre randomised controlled trial on the effect of second-generation narrow band imaging

Abstract

ObjectiveEarly detection of gastric cancer has been the topic of major efforts in high prevalence areas. Whether advanced imaging methods, such as second-generation narrow band imaging (2G-NBI) can improve early detection, is unknown.DesignThis open-label, randomised, controlled tandem trial was conducted in 13 hospitals. Patients at increased risk for gastric cancer were randomly assigned to primary white light imaging (WLI) followed by secondary 2G-NBI (WLI group: n=2258) and primary 2G-NBI followed by secondary WLI (2G-NBI group: n=2265) performed by the same examiner. Suspected early gastric cancer (EGC) lesions in both groups were biopsied. Primary endpoint was the rate of EGC patients in the primary examination. The main secondary endpoint was the positive predictive value (PPV) for EGC in suspicious lesions detected (primary examination).ResultsEGCs were found in 44 (1.9%) and 53 (2.3%; p=0.412) patients in the WLI and 2G-NBI groups, respectively, during primary EGD. In a post hoc analysis, the overall rate of lesions detected at the second examination was 25% (n=36/145), with no significant differences between groups. PPV for EGC in suspicious lesions was 13.5% and 20.9% in the WLI (50/371 target lesions) and 2G-NBI groups (59/282 target lesions), respectively (p=0.015).ConclusionThe overall sensitivity of primary endoscopy for the detection of EGC in high-risk patients was only 75% and should be improved. 2G-NBI did not increase EGC detection rate over conventional WLI. The impact of a slightly better PPV of 2G-NBI has to be evaluated further.Trial registration numberUMIN000014503.

Narrowed-spectrum Technologies in Endoscopic Imaging of The Upper Gastrointestinal Tract

“…74 In a more recent multicenter randomized controlled tandem trial, patients at high-risk for gastric cancer were assigned to undergo examination under WLE followed by second-generation NBI (2258 patients) versus secondgeneration NBI followed by WLE (2265 patients). 75 In this study, the use of NBI did not increase the detection rate of EGC and was associated with a sensitivity of 77.6% compared to 72.5% for WLE. Compared to NBI, next generation NSI systems such as BLI-bright and LCI provide brighter illumination and may help enhance lesion detection.…”

Narrowband imaging with near‐focus magnification for discriminating the gastric tumor margin before endoscopic resection: A prospective randomized multicenter trial

“…demonstrated an improved diagnostic yield of NF‐NBI for upper gastrointestinal mucosal lesions, its diagnostic utility in the stomach was not verified. To our best knowledge, only one study has evaluated the efficacy of NF‐NBI in the stomach until now 15 …”

“…Several studies have reported the diagnostic utility of NF mode with NBI (NF‐NBI) for pharyngeal and esophageal cancers, 12 Barrett's esophagus, 13 and small colonic polyps 14 . Recently, a multicenter randomized controlled trial demonstrated that NF‐NBI did not show improved detection of early gastric cancer (EGC) than white‐light imaging 15 . However, no study has evaluated the utility of NF‐NBI for determining gastric tumor margins.…”

White-light endoscopy versus magnifying narrow-band imaging for diagnosis of the histological subtype of gastric cancer

“…According to the Japanese and Western guidelines [2,5,6], endoscopic resection is adapted regardless of the histological subtype if ulcerative findings were negative in T1a lesions measuring Regarding the study design, we conducted a single-arm trial instead of a randomized controlled trial. WLE is generally used for the detection of suspicious gastric lesions in clinical practice [28]. M-NBI is unlikely to be used without WLE for the diagnosis of gastric cancer, because M-NBI combined with WLE was superior to M-NBI alone in distinguishing gastric cancer from non-cancer [8].…”