Hiroaki Ikematsu1, Taku Sakamoto2, Kazutomo Togashi3, Naohisa Yoshida4, Takashi Hisabe5, Shinsuke Kiriyama6, Koji Matsuda7, Yoshikazu Hayashi8, Takahisa Matsuda2, Shozo Osera1, Kazuhiro Kaneko1, Kenichi Utano3, Yuji Naito4, Hiroshi Ishihara5, Masayuki Kato7, Kenichi Yoshimura9, Hideki Ishikawa10, Hironori Yamamoto8, Yutaka Saito2. 1. Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. 2. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, Aizuwakmatsu, Fukushima, Japan. 4. Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan. 5. Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan. 6. Department of Surgery, Gunma Chuo General Hospital, Maebashi, Gunma, Japan. 7. Department of Endoscopy, The Jikei University Katsushika Medical Center, Tokyo, Japan. 8. Division of Gastroenterology, Department of Medicine, Jichi Medical University, Tochigi, Japan. 9. Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Japan. 10. Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Abstract
BACKGROUND AND AIMS: Most studies have not reported an improvement in the detection of adenomas with the use of image-enhanced colonoscopy methods, possibly because of the darkness of the images. To overcome this limitation, a new-generation endoscopic system has been developed. This system has 2 blue-laser imaging (BLI) observation modes. The BLI observation was set to BLI-bright mode to detect lesions. We aimed to evaluate the efficacy of BLI in detecting lesions. METHODS: This study was designed as a randomized controlled trial with participants from 8 institutions. We enrolled patients aged ≥40 years. The participants were randomly assigned to 2 groups: observation by using white-light imaging (WLI) with a conventional xenon light source (WLI group) or observation by using BLI-bright mode with a laser light source (BLI group). All of the detected lesions were resected or had a biopsy taken for histopathologic analysis. The primary outcome was the mean number of adenomas per patient (MAP) that were detected per procedure. RESULTS: The WLI and BLI groups consisted of 474 and 489 patients, respectively. The MAP was significantly higher in the BLI group than in the WLI group (mean ± standard deviation [SD] WLI 1.01 ± 1.36, BLI 1.27 ± 1.73; P = .008). Adenoma detection rate in the BLI group was not significantly higher than in the WLI group. Observation times differed significantly, with BLI (9.48 minutes) being longer than WLI (8.42; P < .001). The mean (± SD) number of polyps per patient was significantly higher in the BLI group compared with the WLI group (WLI 1.43 ± 1.64, BLI 1.84 ± 2.09; P = .001). CONCLUSIONS: A newly developed system that uses BLI improves the detection of adenomatous lesions compared with WLI. (Clinical trial registration number: UMIN 000014555.).
RCT Entities:
BACKGROUND AND AIMS: Most studies have not reported an improvement in the detection of adenomas with the use of image-enhanced colonoscopy methods, possibly because of the darkness of the images. To overcome this limitation, a new-generation endoscopic system has been developed. This system has 2 blue-laser imaging (BLI) observation modes. The BLI observation was set to BLI-bright mode to detect lesions. We aimed to evaluate the efficacy of BLI in detecting lesions. METHODS: This study was designed as a randomized controlled trial with participants from 8 institutions. We enrolled patients aged ≥40 years. The participants were randomly assigned to 2 groups: observation by using white-light imaging (WLI) with a conventional xenon light source (WLI group) or observation by using BLI-bright mode with a laser light source (BLI group). All of the detected lesions were resected or had a biopsy taken for histopathologic analysis. The primary outcome was the mean number of adenomas per patient (MAP) that were detected per procedure. RESULTS: The WLI and BLI groups consisted of 474 and 489 patients, respectively. The MAP was significantly higher in the BLI group than in the WLI group (mean ± standard deviation [SD] WLI 1.01 ± 1.36, BLI 1.27 ± 1.73; P = .008). Adenoma detection rate in the BLI group was not significantly higher than in the WLI group. Observation times differed significantly, with BLI (9.48 minutes) being longer than WLI (8.42; P < .001). The mean (± SD) number of polyps per patient was significantly higher in the BLI group compared with the WLI group (WLI 1.43 ± 1.64, BLI 1.84 ± 2.09; P = .001). CONCLUSIONS: A newly developed system that uses BLI improves the detection of adenomatous lesions compared with WLI. (Clinical trial registration number: UMIN 000014555.).
Authors: Sharmila Subramaniam; Bu Hayee; Patrick Aepli; Erik Schoon; Milan Stefanovic; Kesavan Kandiah; Sreedhari Thayalasekaran; Asma Alkandari; Paul Bassett; Emmanuel Coron; Oliver Pech; Cesare Hassan; Helmut Neumann; Raf Bisschops; Alessandro Repici; Pradeep Bhandari Journal: United European Gastroenterol J Date: 2019-01-06 Impact factor: 4.623