Toshiaki Watanabe1, Yoichi Ajioka2, Keiichi Mitsuyama3, Kenji Watanabe4, Hiroyuki Hanai5, Hiroshi Nakase6, Reiko Kunisaki7, Keiji Matsuda8, Ryuichi Iwakiri9, Nobuyuki Hida10, Shinji Tanaka11, Yoshiaki Takeuchi12, Kazuo Ohtsuka13, Kazunari Murakami14, Kiyonori Kobayashi15, Yasushi Iwao16, Masakazu Nagahori13, Bunei Iizuka17, Keisuke Hata18, Masahiro Igarashi19, Ichiro Hirata20, Shin-Ei Kudo21, Takayuki Matsumoto22, Fumiaki Ueno23, Gen Watanabe2, Masahiro Ikegami24, Yoko Ito25, Koji Oba26, Eisuke Inoue27, Naoki Tomotsugu25, Toru Takebayashi28, Kenichi Sugihara29, Yasuo Suzuki30, Mamoru Watanabe13, Toshifumi Hibi31. 1. Department of Surgical Oncology and Vascular Surgery, The University of Tokyo, Bunkyo-ku, Tokyo, Japan. Electronic address: toshwatanabe@yahoo.co.jp. 2. Niigata University Graduate School of Medical and Dental Sciences, Chuo-ku, Niigata, Japan. 3. Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan. 4. Department of Gastroenterology, Graduate School of Medicine, Osaka City University, Abeno-ku, Osaka, Japan. 5. Center for Gastroenterology and IBD Research Hamamatsu South Hospital, Minami-ku, Hamamatsu, Japan. 6. Department of Gastroenterology and Hepatology, Endoscopic Medicine, Kyoto University Hospital, Sakyo-ku, Kyoto, Japan. 7. Inflammatory Bowel Disease Center, Yokohama City University Medical Center, Minami-ku, Yokohama, Japan. 8. Department of Surgery, Teikyo University School of Medicine, Itabashi-Ku, Tokyo, Japan. 9. Department of Internal Medicine and Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan. 10. Division of Internal Medicine, Department of Inflammatory Bowel Disease, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan. 11. Department of Endoscopy, Hiroshima University Hospital, Minami-ku, Hiroshima, Japan. 12. Department of Internal Medicine, Showa University School of Medicine, Hatanodai, Shinagawa-ku, Tokyo, Japan. 13. Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan. 14. Department of Gastroenterology, Oita University, Hasama-cho, Yuhu, Oita, Japan. 15. Research and Development Center for New Medical Frontiers, Kitasato University, School of Medicine, Minami, Sagamihara, Kanagawa, Japan. 16. Center for Preventive Medicine, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan. 17. Department of Gastroenterology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan. 18. Department of Surgical Oncology and Vascular Surgery, The University of Tokyo, Bunkyo-ku, Tokyo, Japan. 19. Cancer Institute Ariake Hospital, Koto-ku, Tokyo, Japan. 20. Department of Gastroenterology, Fujita Health University, Kutsukake-Cho, Toyoake, Aichi, Japan. 21. Digestive Disease Center, Showa University Northern Yokohama Hospital, Tsuzuki Yokohama, Japan. 22. Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Morioka, Iwate, Japan. 23. Department of Medicine, Ofuna Chuo Hospital, Kamakura, Kanagawa, Japan. 24. Department of Pathology, The Jikei University, School of Medicine, Minato-ku, Tokyo, Japan. 25. Center for Clinical Research, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan. 26. Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan; Interfaculty Initiative in Information Studies, The University of Tokyo, Bunkyo-ku, Tokyo, Japan. 27. Center for Clinical Research and Development, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan. 28. Department of Preventive Medicine and Public Health, School of Medicine, Keio University, Shinjuku-ku, Tokyo, Japan. 29. Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan. 30. Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Chiba, Japan. 31. Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Minato-ku, Tokyo, Japan.
Abstract
BACKGROUND & AIMS: A random biopsy is recommended for surveillance of ulcerative colitis (UC)-associated colorectal cancer. However, a targeted biopsy might be more effective. We conducted a randomized controlled trial to compare rates of neoplasia detection by targeted vs random biopsies in patients with UC. METHODS: We performed a study of 246 patients with UC for 7 years or more, seen at 52 institutions in Japan from October 1, 2008 through December 31, 2010. Patients were randomly assigned to the random group (4 random biopsies collected every 10 cm in addition to targeted biopsies, n = 122) or the target group (biopsies collected from locations of suspected neoplasia, n = 124). The primary end point was the number of neoplastic lesions detected in a single surveillance colonoscopy. We estimated the ratio and difference in the mean number of neoplastic lesions between the groups. We also evaluated the non-inferiority between the groups as an exploratory study. A non-inferiority margin of 0.65 (0.13 of 0.20) was considered for the ratio of the mean number of neoplastic lesions between groups. RESULTS: The mean number of biopsies found to contain neoplastic tissue per colonoscopy was 0.211 (24 of 114) in the target group and 0.168 (18 of 107) in the random group (ratio of 1.251; 95% confidence interval, 0.679-2.306). The lower limit was above the non-inferiority margin of 0.65. Neoplasias were detected in 11.4% of patients in the target group and 9.3% of patients in the random group (P = .617). Larger numbers of biopsy samples per colonoscopy were collected in the random group (34.8 vs 3.1 in the target group; P < .001), and the total examination time was longer (41.7 vs 26.6 minutes in the target group; P < .001). In the random group, all neoplastic tissues found in random biopsies were collected from areas of the mucosa with a history or presence of inflammation. CONCLUSIONS: In a randomized controlled trial, we found that targeted and random biopsies detect similar proportions of neoplasias. However, a targeted biopsy appears to be a more cost-effective method. Random biopsies from areas without any signs of present or past inflammation were not found to contain neoplastic tissues. Clinical Trial Registry: UMIN000001608. Copyright Â
RCT Entities:
BACKGROUND & AIMS: A random biopsy is recommended for surveillance of ulcerative colitis (UC)-associated colorectal cancer. However, a targeted biopsy might be more effective. We conducted a randomized controlled trial to compare rates of neoplasia detection by targeted vs random biopsies in patients with UC. METHODS: We performed a study of 246 patients with UC for 7 years or more, seen at 52 institutions in Japan from October 1, 2008 through December 31, 2010. Patients were randomly assigned to the random group (4 random biopsies collected every 10 cm in addition to targeted biopsies, n = 122) or the target group (biopsies collected from locations of suspected neoplasia, n = 124). The primary end point was the number of neoplastic lesions detected in a single surveillance colonoscopy. We estimated the ratio and difference in the mean number of neoplastic lesions between the groups. We also evaluated the non-inferiority between the groups as an exploratory study. A non-inferiority margin of 0.65 (0.13 of 0.20) was considered for the ratio of the mean number of neoplastic lesions between groups. RESULTS: The mean number of biopsies found to contain neoplastic tissue per colonoscopy was 0.211 (24 of 114) in the target group and 0.168 (18 of 107) in the random group (ratio of 1.251; 95% confidence interval, 0.679-2.306). The lower limit was above the non-inferiority margin of 0.65. Neoplasias were detected in 11.4% of patients in the target group and 9.3% of patients in the random group (P = .617). Larger numbers of biopsy samples per colonoscopy were collected in the random group (34.8 vs 3.1 in the target group; P < .001), and the total examination time was longer (41.7 vs 26.6 minutes in the target group; P < .001). In the random group, all neoplastic tissues found in random biopsies were collected from areas of the mucosa with a history or presence of inflammation. CONCLUSIONS: In a randomized controlled trial, we found that targeted and random biopsies detect similar proportions of neoplasias. However, a targeted biopsy appears to be a more cost-effective method. Random biopsies from areas without any signs of present or past inflammation were not found to contain neoplastic tissues. Clinical Trial Registry: UMIN000001608. Copyright Â
Authors: William A Bye; Christopher Ma; Tran M Nguyen; Claire E Parker; Vipul Jairath; James E East Journal: Am J Gastroenterol Date: 2018-10-23 Impact factor: 10.864