Clinical trial NCT01925014: Low vs. Standard Dose CT for Appendicitis Trial
Official title: A Multi-institutional Trial Comparing Clinical Outcomes Following Low- vs. Standard-dose Abdominal CT as the First-line Imaging Test in Adolescents and Young Adults With Suspected Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Appendectomy
Appendicitis
False Positive Reactions
Humans
Radiation Dosage
Tomography, X-Ray Computed
Young Adult
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
name: Seoul National University Bundang Hospital
name: Radiology Imaging Network of Korea for Clinical Research
name: The LOCAT Group
First posted: 2013-08-19
Enrollment: 3074
Sex: ALL
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: Negative Appendectomy Rate
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Appendiceal Perforation Rate
timeFrame: 1 week after surgery
measure: Number of Appendectomies
timeFrame: 3 months after CT
measure: Number of Negative Appendectomies
timeFrame: 1 week after surgery
measure: Prevalence of Perforated Appendicitis
timeFrame: 1 week after surgery
measure: Prevalence of Non-perforated Appendicitis
timeFrame: 1 week after surgery
measure: Need for Additional Imaging Test(s)
timeFrame: 1 week after CT
measure: Delay in Patient Disposition
timeFrame: 3 months after CT
measure: Length of Hospital Stay Associated With Appendectomy
timeFrame: 3 months after CT
measure: Diagnostic Performance of CT Reports - AUC
timeFrame: 3 months after CT
measure: Diagnostic Performance of CT Reports - Sensitivity and Specificity
timeFrame: 3 months after CT
measure: Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for Appendicitis
timeFrame: 3 months after CT
measure: Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3)
timeFrame: 3 months after CT
measure: Diagnostic Confidence in Ruling Out Appendicitis: Normal Appendix Visualization
timeFrame: 3 months after CT
measure: Diagnosis of Appendiceal Perforation at CT
timeFrame: 3 months after CT
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Gangwon
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi
city: Sanbon
country: Korea, Republic of
facility: Wonkwang University Sanbon Hospital
state: Gyeonggi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Seongnam
country: Korea, Republic of
facility: Daejin Medical Center, Bundang Jesaeng General Hospital
state: Gyeonggi
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University School of Medicine & Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeju City
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, College of Medicine, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyoung Ho Lee, MD
role: STUDY_CHAIR
affiliation: Seoul National University Bundang Hospital
name: Kyuseok Kim, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.