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Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial

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Author(s)
The LOCAT Group
Keimyung Author(s)
Kwon, Jung HyeokKang, Yu NaKim, Mi JeongBaek, Seong KyuChoi, Woo IkKim, Sung Jin
Department
Dept. of Radiology (영상의학)
Dept. of Pathology (병리학)
Dept. of Surgery (외과학)
Dept. of Emergency Medicine (응급의학)
Journal Title
Lancet
Issued Date
2017
Volume
2
Issue
11
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.
Keimyung Author(s)(Kor)
권중혁
강유나
김미정
백성규
최우익
김성진
Publisher
School of Medicine (의과대학)
Citation
The LOCAT Group. (2017). Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial. Lancet, 2(11), 793–804. doi: 10.1016/S2468-1253(17)30247-9
Type
Article
ISSN
2468-1253
Source
https://linkinghub.elsevier.com/retrieve/pii/S2468125317302479
DOI
10.1016/S2468-1253(17)30247-9
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41341
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Emergency Medicine (응급의학)
1. School of Medicine (의과대학) > Dept. of Pathology (병리학)
1. School of Medicine (의과대학) > Dept. of Radiology (영상의학)
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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