Comparison of Targeted vs Random Biopsies for Surveillance of Ulcerative Colitis-Associated Colorectal Cancer

Toshiaki Watanabe; Yoichi Ajioka; Keiichi Mitsuyama; Kenji Watanabe; Hiroyuki Hanai; Hiroshi Nakase; Reiko Kunisaki; Keiji Matsuda; Ryuichi Iwakiri; Nobuyuki Hida; Shinji Tanaka; Yoshiaki Takeuchi; Kazuo Ohtsuka; Kazunari Murakami; Kiyonori Kobayashi; Yasushi Iwao; Masakazu Nagahori; Bunei Iizuka; Keisuke Hata; Masahiro Igarashi; Ichiro Hirata; Shin ei Kudo; Takayuki Matsumoto; Fumiaki Ueno; Gen Watanabe; Masahiro Ikegami; Yoko Ito; Koji Oba; Eisuke Inoue; Naoki Tomotsugu; Toru Takebayashi; Kenichi Sugihara; Yasuo Suzuki; Mamoru Watanabe; Toshifumi Hibi

doi:10.1053/j.gastro.2016.08.002

Comparison of Targeted vs Random Biopsies for Surveillance of Ulcerative Colitis-Associated Colorectal Cancer

Toshiaki Watanabe, Yoichi Ajioka, Keiichi Mitsuyama, Kenji Watanabe, Hiroyuki Hanai, Hiroshi Nakase, Reiko Kunisaki, Keiji Matsuda, Ryuichi Iwakiri, Nobuyuki Hida, Shinji Tanaka, Yoshiaki Takeuchi, Kazuo Ohtsuka, Kazunari Murakami, Kiyonori Kobayashi, Yasushi Iwao, Masakazu Nagahori, Bunei Iizuka, Keisuke Hata, Masahiro IgarashiIchiro Hirata, Shin ei Kudo, Takayuki Matsumoto, Fumiaki Ueno, Gen Watanabe, Masahiro Ikegami, Yoko Ito, Koji Oba, Eisuke Inoue, Naoki Tomotsugu, Toru Takebayashi, Kenichi Sugihara, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi

Research output: Contribution to journal › Article › peer-review

151 Citations (Scopus)

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.

Original language	English
Pages (from-to)	1122-1130
Number of pages	9
Journal	Gastroenterology
Volume	151
Issue number	6
DOIs	https://doi.org/10.1053/j.gastro.2016.08.002
Publication status	Published - 2016 Dec 1

Keywords

Colonoscopy
Dysplasia
IBD
Random Biopsy

ASJC Scopus subject areas

Hepatology
Gastroenterology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1053/j.gastro.2016.08.002

Cite this

Watanabe, T., Ajioka, Y., Mitsuyama, K., Watanabe, K., Hanai, H., Nakase, H., Kunisaki, R., Matsuda, K., Iwakiri, R., Hida, N., Tanaka, S., Takeuchi, Y., Ohtsuka, K., Murakami, K., Kobayashi, K., Iwao, Y., Nagahori, M., Iizuka, B., Hata, K., ... Hibi, T. (2016). Comparison of Targeted vs Random Biopsies for Surveillance of Ulcerative Colitis-Associated Colorectal Cancer. Gastroenterology, 151(6), 1122-1130. https://doi.org/10.1053/j.gastro.2016.08.002

Watanabe, T, Ajioka, Y, Mitsuyama, K, Watanabe, K, Hanai, H, Nakase, H, Kunisaki, R, Matsuda, K, Iwakiri, R, Hida, N, Tanaka, S, Takeuchi, Y, Ohtsuka, K, Murakami, K, Kobayashi, K, Iwao, Y, Nagahori, M, Iizuka, B, Hata, K, Igarashi, M, Hirata, I, Kudo, SE, Matsumoto, T, Ueno, F, Watanabe, G, Ikegami, M, Ito, Y, Oba, K, Inoue, E, Tomotsugu, N, Takebayashi, T, Sugihara, K, Suzuki, Y, Watanabe, M & Hibi, T 2016, 'Comparison of Targeted vs Random Biopsies for Surveillance of Ulcerative Colitis-Associated Colorectal Cancer', Gastroenterology, vol. 151, no. 6, pp. 1122-1130. https://doi.org/10.1053/j.gastro.2016.08.002

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title = "Comparison of Targeted vs Random Biopsies for Surveillance of Ulcerative Colitis-Associated Colorectal Cancer",

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.",

keywords = "Colonoscopy, Dysplasia, IBD, Random Biopsy",

author = "Toshiaki Watanabe and Yoichi Ajioka and Keiichi Mitsuyama and Kenji Watanabe and Hiroyuki Hanai and Hiroshi Nakase and Reiko Kunisaki and Keiji Matsuda and Ryuichi Iwakiri and Nobuyuki Hida and Shinji Tanaka and Yoshiaki Takeuchi and Kazuo Ohtsuka and Kazunari Murakami and Kiyonori Kobayashi and Yasushi Iwao and Masakazu Nagahori and Bunei Iizuka and Keisuke Hata and Masahiro Igarashi and Ichiro Hirata and Kudo, {Shin ei} and Takayuki Matsumoto and Fumiaki Ueno and Gen Watanabe and Masahiro Ikegami and Yoko Ito and Koji Oba and Eisuke Inoue and Naoki Tomotsugu and Toru Takebayashi and Kenichi Sugihara and Yasuo Suzuki and Mamoru Watanabe and Toshifumi Hibi",

note = "Funding Information: Funding This study was supported by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan, an Intractable Diseases, the Health and Labour Sciences Research Grant from Ministry of Health, Labour and Welfare of Japan and Grants by JSCCR (to Toshiaki Watanabe). The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. Publisher Copyright: {\textcopyright} 2016 AGA Institute",

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month = dec,

day = "1",

doi = "10.1053/j.gastro.2016.08.002",

language = "English",

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TY - JOUR

T1 - Comparison of Targeted vs Random Biopsies for Surveillance of Ulcerative Colitis-Associated Colorectal Cancer

AU - Watanabe, Toshiaki

AU - Ajioka, Yoichi

AU - Mitsuyama, Keiichi

AU - Watanabe, Kenji

AU - Hanai, Hiroyuki

AU - Nakase, Hiroshi

AU - Kunisaki, Reiko

AU - Matsuda, Keiji

AU - Iwakiri, Ryuichi

AU - Hida, Nobuyuki

AU - Tanaka, Shinji

AU - Takeuchi, Yoshiaki

AU - Ohtsuka, Kazuo

AU - Murakami, Kazunari

AU - Kobayashi, Kiyonori

AU - Iwao, Yasushi

AU - Nagahori, Masakazu

AU - Iizuka, Bunei

AU - Hata, Keisuke

AU - Igarashi, Masahiro

AU - Hirata, Ichiro

AU - Kudo, Shin ei

AU - Matsumoto, Takayuki

AU - Ueno, Fumiaki

AU - Watanabe, Gen

AU - Ikegami, Masahiro

AU - Ito, Yoko

AU - Oba, Koji

AU - Inoue, Eisuke

AU - Tomotsugu, Naoki

AU - Takebayashi, Toru

AU - Sugihara, Kenichi

AU - Suzuki, Yasuo

AU - Watanabe, Mamoru

AU - Hibi, Toshifumi

N1 - Funding Information: Funding This study was supported by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan, an Intractable Diseases, the Health and Labour Sciences Research Grant from Ministry of Health, Labour and Welfare of Japan and Grants by JSCCR (to Toshiaki Watanabe). The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. Publisher Copyright: © 2016 AGA Institute

PY - 2016/12/1

Y1 - 2016/12/1

N2 - 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.

AB - 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.

KW - Colonoscopy

KW - Dysplasia

KW - IBD

KW - Random Biopsy

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