10 Citations (Scopus)

Abstract

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, randomised 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 analysis 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.

Original languageEnglish
Pages (from-to)793-804
Number of pages12
JournalThe Lancet Gastroenterology and Hepatology
Volume2
Issue number11
DOIs
StatePublished - Nov 2017

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Appendicitis
Young Adult
Appendectomy
Radiation
Korea
Background Radiation
Non-Randomized Controlled Trials
Biological Science Disciplines
Anaphylaxis
Random Allocation
Teaching Hospitals
Contrast Media
Industry
Retrospective Studies
Health

Cite this

@article{6505ea0f67f44c49b57c96ec3354988e,
title = "Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial",
abstract = "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, randomised 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 analysis 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.",
author = "{The LOCAT Group} and Kim, {Hyuk Jung} and Jeon, {Byeong Geon} and Hong, {Chong Kun} and Kwon, {Kye Won} and Han, {Seung Bong} and Soya Paik and Jang, {Suk Ki} and Ha, {Young Rock} and Kim, {Young Sik} and Lee, {Min Hee} and Yi, {Boem Ha} and Shin, {Eung Jin} and Lee, {Hae Kyung} and Kim, {Hee Kyung} and Kim, {Ho Jung} and Choi, {Jae Hyung} and Cho, {Young Soon} and Kim, {Min Jeong} and Kim, {Dong Kyu} and Choe, {Ji Young} and Min, {Kyueng Whan} and Lim, {Man Sup} and Ha, {Sang Ook} and Lim, {Sang Woo} and Sohn, {You Dong} and Lee, {Young Hwan} and Park, {Ji Hoon} and Gu, {Bon Seung} and Lee, {Hye Seung} and Jae-Hyuk Lee and Sim, {Ji Ye} and Joonghee Kim and Kyoungho Lee and Kyuseok Kim and Ahn, {So Yeon} and Kang, {Sung Bum} and Lee, {Yoon Jin} and Jo, {You Hwan} and Kim, {Young Hoon} and Yousun Ko and Choi, {Seung Joon} and Bohyung Song and Goh, {Byung Ho} and Shin, {Cheong Il} and Gyeonghoon Kang and Joo, {I Jin} and Park, {Ji Won} and Park, {Kyu Joo} and Ryoo, {Seung Bum} and Won Chang",
year = "2017",
month = "11",
doi = "10.1016/S2468-1253(17)30247-9",
language = "English",
volume = "2",
pages = "793--804",
journal = "The Lancet Gastroenterology and Hepatology",
issn = "2468-1253",
publisher = "Elsevier Ltd",
number = "11",

}

TY - JOUR

T1 - Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT)

T2 - a pragmatic, multicentre, randomised controlled non-inferiority trial

AU - The LOCAT Group

AU - Kim, Hyuk Jung

AU - Jeon, Byeong Geon

AU - Hong, Chong Kun

AU - Kwon, Kye Won

AU - Han, Seung Bong

AU - Paik, Soya

AU - Jang, Suk Ki

AU - Ha, Young Rock

AU - Kim, Young Sik

AU - Lee, Min Hee

AU - Yi, Boem Ha

AU - Shin, Eung Jin

AU - Lee, Hae Kyung

AU - Kim, Hee Kyung

AU - Kim, Ho Jung

AU - Choi, Jae Hyung

AU - Cho, Young Soon

AU - Kim, Min Jeong

AU - Kim, Dong Kyu

AU - Choe, Ji Young

AU - Min, Kyueng Whan

AU - Lim, Man Sup

AU - Ha, Sang Ook

AU - Lim, Sang Woo

AU - Sohn, You Dong

AU - Lee, Young Hwan

AU - Park, Ji Hoon

AU - Gu, Bon Seung

AU - Lee, Hye Seung

AU - Lee, Jae-Hyuk

AU - Sim, Ji Ye

AU - Kim, Joonghee

AU - Lee, Kyoungho

AU - Kim, Kyuseok

AU - Ahn, So Yeon

AU - Kang, Sung Bum

AU - Lee, Yoon Jin

AU - Jo, You Hwan

AU - Kim, Young Hoon

AU - Ko, Yousun

AU - Choi, Seung Joon

AU - Song, Bohyung

AU - Goh, Byung Ho

AU - Shin, Cheong Il

AU - Kang, Gyeonghoon

AU - Joo, I Jin

AU - Park, Ji Won

AU - Park, Kyu Joo

AU - Ryoo, Seung Bum

AU - Chang, Won

PY - 2017/11

Y1 - 2017/11

N2 - 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, randomised 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 analysis 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.

AB - 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, randomised 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 analysis 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.

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U2 - 10.1016/S2468-1253(17)30247-9

DO - 10.1016/S2468-1253(17)30247-9

M3 - Article

C2 - 28919126

AN - SCOPUS:85031308935

VL - 2

SP - 793

EP - 804

JO - The Lancet Gastroenterology and Hepatology

JF - The Lancet Gastroenterology and Hepatology

SN - 2468-1253

IS - 11

ER -