Study Results
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View full resultsBasic Information
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COMPLETED
NA
3074 participants
INTERVENTIONAL
2013-12-31
2017-02-28
Brief Summary
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Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
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Detailed Description
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* CT is the current standard imaging test for the diagnosis of appendicitis.
* In recent years, the awareness of carcinogenic risk associated with CT radiation has increased.
* According to a recent single-institutional randomized controlled trial, LD CT (employing a quarter of standard radiation dose) was found to be noninferior to SD CT with respect to NARs in adolescents and young adults with suspected appendicitis.
* However, LD CT is not yet widely accepted.
* To establish LD CT as the first-line imaging test, a multi-institutional study is needed to confirm the generalizability of the prior single-institutional study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Low-dose CT
Diagnostic CT with low-dose radiation
Diagnostic CT with low-dose radiation
Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.
Standard-dose CT
Diagnostic CT with standard-dose radiation
Diagnostic CT with standard-dose radiation
Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.
Interventions
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Diagnostic CT with low-dose radiation
Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.
Diagnostic CT with standard-dose radiation
Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis
* Willing to provide telephone or cell phone numbers for follow-up
* Signed informed consent provided prior to study entry
Exclusion Criteria
* Prior history of surgical removal of the appendix
15 Years
44 Years
ALL
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Seoul National University Bundang Hospital
OTHER
Radiology Imaging Network of Korea for Clinical Research
OTHER
The LOCAT Group
UNKNOWN
Kyoung Ho Lee, MD
OTHER
Responsible Party
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Kyoung Ho Lee, MD
Professor
Principal Investigators
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Kyoung Ho Lee, MD
Role: STUDY_CHAIR
Seoul National University Bundang Hospital
Kyuseok Kim, MD
Role: STUDY_DIRECTOR
Seoul National University Bundang Hospital
Locations
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Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Wonkwang University Sanbon Hospital
Sanbon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Daejin Medical Center, Bundang Jesaeng General Hospital
Seongnam-si, Gyeonggi-do, South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Wonkwang University School of Medicine & Hospital
Iksan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea, College of Medicine, Seoul St. Mary's Hospital
Seoul, , South Korea
Soonchunhyang University Seoul Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Countries
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References
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Kim K, Kim YH, Kim SY, Kim S, Lee YJ, Kim KP, Lee HS, Ahn S, Kim T, Hwang SS, Song KJ, Kang SB, Kim DW, Park SH, Lee KH. Low-dose abdominal CT for evaluating suspected appendicitis. N Engl J Med. 2012 Apr 26;366(17):1596-605. doi: 10.1056/NEJMoa1110734.
Ahn S; LOCAT group. LOCAT (low-dose computed tomography for appendicitis trial) comparing clinical outcomes following low- vs standard-dose computed tomography as the first-line imaging test in adolescents and young adults with suspected acute appendicitis: study protocol for a randomized controlled trial. Trials. 2014 Jan 17;15:28. doi: 10.1186/1745-6215-15-28.
Ko Y, Choi JW, Kim DH, Lee KJ, Shin SS, Woo JY, Cho SW, Kim BS, Lee KH. Central image archiving and management system for multicenter clinical studies: lessons from low-dose CT for appendicitis trial. J Korean Soc Radiol. 2017 Mar 28;76(3):165-72. doi: 10.3348/jksr.2017.76.3.165.
Yang HK, Ko Y, Lee MH, Woo H, Ahn S, Kim B, Pickhardt PJ, Kim MS, Park SB, Lee KH; Low-Dose CT for Appendicitis Trial (LOCAT) Group. Initial Performance of Radiologists and Radiology Residents in Interpreting Low-Dose (2-mSv) Appendiceal CT. AJR Am J Roentgenol. 2015 Dec;205(6):W594-611. doi: 10.2214/AJR.15.14513.
Kim HY, Lee S, Kim DH, Ko Y, Park JH, Ko A, Jeong SM, Park SB, Lee KH; LOCAT Group. Conventional-Dose CT Versus 2-mSv CT for Right Colonic Diverticulitis as an Alternate Diagnosis of Appendicitis: Secondary Analysis of Large Pragmatic Randomized Trial Data. AJR Am J Roentgenol. 2021 Nov;217(5):1113-1121. doi: 10.2214/AJR.21.25584. Epub 2021 Apr 7.
LOCAT Group. Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):793-804. doi: 10.1016/S2468-1253(17)30247-9. Epub 2017 Sep 12.
Related Links
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LOCAT-Training, a self-learning course to train the radiologists at all Sites to ensure the safety of the participants.
Other Identifiers
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LOCAT
Identifier Type: -
Identifier Source: org_study_id
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