Hiroshi Saito1,2, Shin-Ei Kudo3, Noriaki Takahashi4,5, Seiichiro Yamamoto6, Kenta Kodama7, Koichi Nagata5,8, Yuri Mizota6, Fumio Ishida3, Yasuo Ohashi9. 1. Aomori Prefectural Central Hospital, 2-1-1 Higashi-Tsukurimichi, Aomori, 030-8553, Japan. hrsaito@med.pref.aomori.jp. 2. Division of Medical Support and Partnership, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan. hrsaito@med.pref.aomori.jp. 3. Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan. 4. Division of Screening Assessment and Management, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan. 5. Cancer Screening Center, National Cancer Center Hospital, Tokyo, Japan. 6. Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan. 7. Department of Gastroenterology, Japanese Red Cross Fukushima Hospital, Fukushima, Japan. 8. Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan. 9. Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.
Abstract
PURPOSE: Screening programs using fecal occult blood testing help reduce mortality from colorectal cancer (CRC). Colonoscopy and colonoscopy combined with fecal occult blood testing are considered alternatives with higher sensitivity than fecal tests; however, to our knowledge, randomized controlled trials (RCTs) providing such evidence have not been reported. Therefore, this study aimed to compare screening using the fecal immunochemical test (FIT) combined with colonoscopy and FIT alone to evaluate the efficacy of colonoscopy screening in reducing CRC mortality. METHODS: This multicenter, prospective, randomized, controlled study included average-risk individuals for CRC living in the study areas and aged 40-74 years. The exclusion criteria were history of CRC, hereditary non-polyposis CRC, familial adenomatous polyposis, inflammatory bowel diseases, history of cancer other than CRC within the past 5 years, and not expected to survive from comorbid illness. The intervention group underwent one-time colonoscopy and annual FIT, while the control group underwent annual FIT. The primary endpoint was mortality from CRC, while the secondary endpoints were cumulative incidence of invasive CRC, advanced CRC (invasion into the muscle layer or deeper), invasive cancer and screening sensitivities and specificities of invasive CRC, whole CRC, advanced neoplasia, and prevalence of adverse events. The intervention and control groups comprised 4876 and 4875 participants, respectively. CONCLUSION: This explanatory RCT evaluated the efficacy of colonoscopy screening by valid statistical inference based on randomization. Data on adverse events from this kind of screening are necessary when considering implementation of future screening programs. TRIAL REGISTRATION: UMIN Clinical Trials Registry, number UMIN000001980.
RCT Entities:
PURPOSE: Screening programs using fecal occult blood testing help reduce mortality from colorectal cancer (CRC). Colonoscopy and colonoscopy combined with fecal occult blood testing are considered alternatives with higher sensitivity than fecal tests; however, to our knowledge, randomized controlled trials (RCTs) providing such evidence have not been reported. Therefore, this study aimed to compare screening using the fecal immunochemical test (FIT) combined with colonoscopy and FIT alone to evaluate the efficacy of colonoscopy screening in reducing CRCmortality. METHODS: This multicenter, prospective, randomized, controlled study included average-risk individuals for CRC living in the study areas and aged 40-74 years. The exclusion criteria were history of CRC, hereditary non-polyposis CRC, familial adenomatous polyposis, inflammatory bowel diseases, history of cancer other than CRC within the past 5 years, and not expected to survive from comorbid illness. The intervention group underwent one-time colonoscopy and annual FIT, while the control group underwent annual FIT. The primary endpoint was mortality from CRC, while the secondary endpoints were cumulative incidence of invasive CRC, advanced CRC (invasion into the muscle layer or deeper), invasive cancer and screening sensitivities and specificities of invasive CRC, whole CRC, advanced neoplasia, and prevalence of adverse events. The intervention and control groups comprised 4876 and 4875 participants, respectively. CONCLUSION: This explanatory RCT evaluated the efficacy of colonoscopy screening by valid statistical inference based on randomization. Data on adverse events from this kind of screening are necessary when considering implementation of future screening programs. TRIAL REGISTRATION: UMIN Clinical Trials Registry, number UMIN000001980.
Authors: Maureen A Smith; Jennifer M Weiss; Aaron Potvien; Jessica R Schumacher; Ronald E Gangnon; David H Kim; Lauren A Weeth-Feinstein; Perry J Pickhardt Journal: Radiology Date: 2017-07-11 Impact factor: 11.105
Authors: Øyvind Holme; Magnus Løberg; Mette Kalager; Michael Bretthauer; Miguel A Hernán; Eline Aas; Tor J Eide; Eva Skovlund; Jørn Schneede; Kjell Magne Tveit; Geir Hoff Journal: JAMA Date: 2014-08-13 Impact factor: 56.272
Authors: Robert E Schoen; Paul F Pinsky; Joel L Weissfeld; Lance A Yokochi; Timothy Church; Adeyinka O Laiyemo; Robert Bresalier; Gerald L Andriole; Saundra S Buys; E David Crawford; Mona N Fouad; Claudine Isaacs; Christine C Johnson; Douglas J Reding; Barbara O'Brien; Danielle M Carrick; Patrick Wright; Thomas L Riley; Mark P Purdue; Grant Izmirlian; Barnett S Kramer; Anthony B Miller; John K Gohagan; Philip C Prorok; Christine D Berg Journal: N Engl J Med Date: 2012-05-21 Impact factor: 91.245
Authors: Leo G van Rossum; Anne F van Rijn; Robert J Laheij; Martijn G van Oijen; Paul Fockens; Han H van Krieken; Andre L Verbeek; Jan B Jansen; Evelien Dekker Journal: Gastroenterology Date: 2008-03-25 Impact factor: 22.682
Authors: Jason A Dominitz; Douglas J Robertson; Dennis J Ahnen; James E Allison; Margaret Antonelli; Kathy D Boardman; Maria Ciarleglio; Barbara J Del Curto; Grant D Huang; Thomas F Imperiale; Meaghan F Larson; David Lieberman; Theresa O'Connor; Timothy J O'Leary; Peter Peduzzi; Dawn Provenzale; Aasma Shaukat; Shahnaz Sultan; Amy Voorhees; Robert Wallace; Peter D Guarino Journal: Am J Gastroenterol Date: 2017-10-10 Impact factor: 10.864
Authors: Michael Bretthauer; Michal F Kaminski; Magnus Løberg; Ann G Zauber; Jaroslaw Regula; Ernst J Kuipers; Miguel A Hernán; Eleanor McFadden; Annike Sunde; Mette Kalager; Evelien Dekker; Iris Lansdorp-Vogelaar; Kjetil Garborg; Maciej Rupinski; Manon C W Spaander; Marek Bugajski; Ole Høie; Tryggvi Stefansson; Geir Hoff; Hans-Olov Adami Journal: JAMA Intern Med Date: 2016-07-01 Impact factor: 21.873
Authors: U Strömberg; C Bonander; M Westerberg; L Å Levin; C Metcalfe; R Steele; L Holmberg; A Forsberg; R Hultcrantz Journal: EClinicalMedicine Date: 2022-04-16