1. Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial
- Author
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Hyuk Jung Kim, Byeong Geon Jeon, Chong Kun Hong, Kye Won Kwon, Seung Bong Han, Soya Paik, Suk Ki Jang, Young Rock Ha, Young Sik Kim, Min Hee Lee, Boem Ha Yi, Eung Jin Shin, Hae Kyung Lee, Hee Kyung Kim, Ho Jung Kim, Jae Hyung Choi, Young Soon Cho, Min-Jeong Kim, Dong Kyu Kim, Ji-Young Choe, Kyueng-Whan Min, Man Sup Lim, Sang Ook Ha, Sang Woo Lim, Youdong Sohn, Young Hwan Lee, Ji Hoon Park, Bon Seung Gu, Hye Seung Lee, Jae Hyuk Lee, Ji Ye Sim, Joonghee Kim, Kyoung Ho Lee, Kyuseok Kim, Soyeon Ahn, Sung-Bum Kang, Yoon Jin Lee, You Hwan Jo, Young Hoon Kim, Yousun Ko, Seung Joon Choi, Bohyung Song, Byung Ho Goh, Chaesuk Lim, Chang Rae Kim, Cho Rong Seo, Eunbaeck Kim, Gio Han, Jae-Hyug Woo, Jinhyun Kim, Kyoungjin Min, Min-A Lee, Min Ju Jeong, Min Kyoung Lee, Yong Su Lim, Young Sup Shim, Sung Bin Park, Chan Woong Kim, Dong Hoon Lee, Seung Eun Lee, Sung Eun Kim, Yoo Shin Choi, Sung Eun Rha, Eun Sun Jung, Gun Hyung Na, Han Joon Kim, Han Mo Yoo, Hye Kyung Chang, Joon Il Choi, Kyu Nam Park, Michael Yong Park, Moon Hyung Choi, Sang Hoon Oh, Seung Eun Jung, Sohee Lee, Soo Ah Im, Soo Hyun Kim, Soon Nam Oh, Tae Ho Hong, Won-Kyung Kang, Young Joon Lee, Dong Baek Kang, Hyun Soo Han, Jeong Woo Choi, Ki-Jung Yoon, Yong Hwang, Seong Sook Hong, Eui Sung Hwang, Heajin Chung, Hye Young Jang, Jiyoung Hwang, Jun Bum Park, Kyung Yul Hur, Yoon Mi Jeen, Young Joo Lee, Young Shin Cho, Han Jin Cho, Inyoung Choi, Jong Hak Park, Jooyeong Kim, Suk Keu Yeom, Sung Woo Moon, Mi Sung Kim, Dong Hyuk Shin, Heon-Ju Kwon, Pil Cho Choi, Sang Kuk Han, Ji Young Woo, Gu Hyun Kang, Han Myun Kim, Hyun Young Choi, Ik Yang, Jae Ho Jang, Jeong Won Kim, Sang Nam Yoon, Won Hee Kim, Yong Soo Jang, Mi-Suk Park, In Cheol Park, Jae Gil Lee, Min Joung Kim, Yong Eun Chung, Jongmee Lee, Baek-Hui Kim, Chang Hee Lee, Jung-Youn Kim, Sanghee Kang, Sung-Hyuk Choi, Yang Shin Park, Seong Whi Cho, Chan Woo Park, Gi Bong Chae, Taek Guen Ohk, Yong-Hwan Jeon, Nurhee Hong, Dae Han Wi, Jun Hee Lee, Jung Nam Kwon, Seok Youn Lee, Weon-Cheol Han, Young Cheol Song, Mi Jeong Kim, Jung Hyeok Kwon, Seoung Kyu Beak, Sung Jin Kim, Woo Ik Choi, Yu Na Kang, Cheong-Il Shin, Dong Ho Lee, Gyeong Hoon Kang, Ijin Joo, Jeong Hee Yoon, Ji Won Park, Kyu Joo Park, Sang Do Shin, Seung-Bum Ryoo, Seung-Yong Jeong, Su Joa Ahn, Tae Han Kim, Won Chang, Yoon-Hye Kwon, Sang Soo Shin, Hee Joon Kim, Ho Goon Kim, Yong Soo Cho, Yoo Duk Choi, Bong Soo Kim, Chang Lim Hyun, Guk Myung Choi, In Ho Jeong, Kyeong Won Kang, Seung Hyoung Kim, Woo Jeong Kim, Young Joon Kang, and Kwang Pyo Kim
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Adult ,Male ,Pediatrics ,medicine.medical_specialty ,Adolescent ,Contrast Media ,Radiation Dosage ,030218 nuclear medicine & medical imaging ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Iodinated contrast ,medicine ,Clinical endpoint ,Humans ,Low dose ct ,Young adult ,Adverse effect ,Intention-to-treat analysis ,Hepatology ,business.industry ,Gastroenterology ,Appendicitis ,medicine.disease ,Intention to Treat Analysis ,030220 oncology & carcinogenesis ,Acute Disease ,Non inferiority trial ,Female ,Tomography, X-Ray Computed ,business - Abstract
Summary Background CT radiation is arguably carcinogenic. Results from single-centre studies, mostly retrospective, have advocated lowering the CT radiation dose for the diagnosis of appendicitis. However, adoption of low-dose CT has been slow. We aimed to assess the effectiveness of low-dose CT compared with standard-dose CT in the diagnosis of appendicitis in adolescents and young adults. Methods We did this pragmatic, multicentre, randomi s ed controlled non-inferiority trial at 20 South Korean teaching hospitals with little experience with low-dose CT. Patients aged 15–44 years with suspected appendicitis were randomly assigned (1:1), via computer-generated random assignments (permuted block sizes of two, four, six, and eight) concealed in sequentially numbered envelopes, to receive low-dose CT (2 mSv) or standard-dose CT (≤8 mSv). Randomisation was stratified by site. Group allocation was concealed from patients, outcome assessors, and adverse event adjudicators; care providers, site pathologists, and data collectors were aware of allocation. The primary endpoint was the negative (unnecessary) appendectomy rate among all appendectomies, with a non-interiority margin of 4·5% for low-dose versus standard-dose CT. Primary analy s is was by modified intention to treat, which included all patients who received an appendectomy in the group to which they were assigned. This trial is registered with ClinicalTrials.gov, number NCT01925014. Findings Between Dec 4, 2013, and Aug 18, 2016, we assigned 1535 patients to the low-dose CT group and 1539 patients to the standard-dose CT group. 22 (3·9%) of 559 patients had a negative appendectomy in the low-dose group versus 16 (2·7%) of 601 patients in the standard-dose group (difference 1·3%, 95% CI −0·8 to 3·3; p=0·0022 for the non-inferiority test). We recorded 43 adverse events in 43 (2·8%) of 1535 patients in the low-dose group and 41 adverse events in 40 (2·6%) of 1539 patients in the standard-dose group. One life-threatening adverse event of anaphylaxis caused by an iodinated contrast material occurred in the low-dose group. Interpretation Radiation dose of appendiceal CT for adolescents and young adults can be reduced to 2 mSv without impairing clinical outcomes. In view of the vast number of appendiceal CT examinations done worldwide, use of low-dose CT could prevent a sizeable number of radiation-associated cancers in the future. Funding Korea Health Industry Development Institute, Seoul National University Bundang Hospital, Dasol Life Science, and Bracco Imaging Korea.
- Published
- 2017
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