Low vs. Standard Dose CT for Appendicitis Trial

NCT ID: NCT01925014

Last Updated: 2019-01-31

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3074 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-02-28

Brief Summary

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To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed tomography (CT) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (NAR).

Detailed Description

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* Acute appendicitis is a very common disease. Many patients are adolescents or young adults.
* 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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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Low-dose CT

Diagnostic CT with low-dose radiation

Group Type EXPERIMENTAL

Diagnostic CT with low-dose radiation

Intervention Type DIAGNOSTIC_TEST

Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.

Standard-dose CT

Diagnostic CT with standard-dose radiation

Group Type ACTIVE_COMPARATOR

Diagnostic CT with standard-dose radiation

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Diagnostic CT with standard-dose radiation

Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Low-dose CT Standard-dose CT

Eligibility Criteria

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Inclusion Criteria

* Emergency department visit with suspected symptoms and signs of acute appendicitis
* 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 cross-sectional imaging tests to evaluate the presenting symptoms and signs
* Prior history of surgical removal of the appendix
Minimum Eligible Age

15 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Radiology Imaging Network of Korea for Clinical Research

OTHER

Sponsor Role collaborator

The LOCAT Group

UNKNOWN

Sponsor Role collaborator

Kyoung Ho Lee, MD

OTHER

Sponsor Role lead

Responsible Party

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Kyoung Ho Lee, MD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Wonkwang University Sanbon Hospital

Sanbon, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Daejin Medical Center, Bundang Jesaeng General Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Wonkwang University School of Medicine & Hospital

Iksan, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Jeju National University Hospital

Jeju City, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

The Catholic University of Korea, College of Medicine, Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Soonchunhyang University Seoul Hospital

Seoul, , South Korea

Site Status

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

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.

Reference Type BACKGROUND
PMID: 22533576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24438500 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 26587949 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33825498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28919126 (View on PubMed)

Related Links

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http://www.locat.org/locat_training

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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