Low vs. Standard Dose CT for Appendicitis Trial (LOCAT)

This study is currently recruiting participants.
Verified December 2013 by Seoul National University Bundang Hospital
Sponsor:
Collaborators:
Ministry of Health & Welfare, Korea
Seoul National University Bundang Hospital
Dasol Life Science Inc.
Information provided by (Responsible Party):
Kyoung Ho Lee, MD, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01925014
First received: August 15, 2013
Last updated: December 22, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Appendicitis
Radiation: Diagnostic CT with low-dose radiation
Radiation: Diagnostic CT with standard-dose radiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Negative appendectomy rate [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]
    Negative appendectomy rate is defined as the percentage of negative (unnecessary) appendectomies out of all non-incidental appendectomies. As a secondary analysis, negative appendectomy rate in an alternative definition is calculated by excluding cases with appendiceal neoplasms without superimposed appendicitis, as appendectomy would be clinically necessary in such patients. Any surgery performed for the treatment of presumed appendicitis is counted as non-incidental appendectomy, even though the surgical procedures may be more extensive than simple appendectomy (e.g., ileocectomy).


Secondary Outcome Measures:
  • Appendiceal perforation rate [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]
    The percentage of perforated appendicitis of all confirmed appendicitis cases.

  • Additional Imaging Test(s) [ Time Frame: 1 week after CT ] [ Designated as safety issue: No ]
    The proportion of patients requiring additional imaging test(s) in order to diagnose or rule out appendicitis.

  • Delay in patient disposition [ Time Frame: 1 day after surgery ] [ Designated as safety issue: No ]
    • Interval from CT acquisition to appendectomy in patients undergoing non-incidental appendectomy. Interval appendectomies following percutaneous abscess drainage are not included in this analysis.
    • Interval from CT acquisition to hospital discharge in patients not undergoing surgery.

  • Hospital stay associated with non-incidental appendectomy [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]
    The interval from CT acquisition to hospital discharge after non-incidental appendectomy.

  • Diagnostic performance of CT reports [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]
    • Area under receiver-operating-characteristic curve.
    • Diagnostic sensitivity and specificity: for calculation of the sensitivity and specificity, the 5-grade likelihood scores for appendicitis are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis. This decision threshold is based on the fact that appendicitis is actually present in 13-73% of patients with CT scans interpreted as equivocal and that appendiceal perforation as a consequence of a false-negative diagnosis is considered more harmful to patients than a negative appendectomy as a consequence of a false-positive diagnosis.

  • Diagnostic confidence in diagnosing and ruling out appendicitis [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]
    • Likelihood score for appendicitis in patients confirmed as having appendicitis.
    • Likelihood score for appendicitis in patients confirmed as not having appendicitis.
    • The frequency of indeterminate CT interpretation (grade 3).
    • The frequency of normal appendix visualization at CT.

  • Diagnosis of appendiceal perforation at CT [ Time Frame: 3 months after CT ] [ Designated as safety issue: No ]
    • Diagnostic sensitivity: the number of correct detections of the perforation divided by the number of cases of perforated appendicitis.
    • Diagnostic specificity: the number of correct ruling out the perforation divided by the number of cases of appendicitis without perforation.


Estimated Enrollment: 3000
Study Start Date: December 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-dose CT
Diagnostic CT with low-dose radiation
Radiation: Diagnostic CT with low-dose radiation
Effective dose is aimed at approximately 8 millisievert in an average patient.
Other Name: Low-dose CT
Active Comparator: Standard-dose CT
Diagnostic CT with standard-dose radiation
Radiation: Diagnostic CT with standard-dose radiation
Effective dose is aimed at approximately 2 millisievert in an average patient.
Other Name: Standard-dose CT

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

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01925014

Contacts
Contact: Kyoung Ho Lee, MD 82-31-787-7609 kholeemail@gmail.com
Contact: Ji Hoon Park, MD 87-31-787-7619 pjihoon79@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Seoul, Korea, Republic of, 463-707
Contact: Ji Hoon Park, MD    821073387609    pjihoon79@gmail.com   
Principal Investigator: Ji Hoon Park, MD         
Sub-Investigator: Yoon Jin Lee, MD         
Sub-Investigator: Yong Hwan Chung, RT         
Sub-Investigator: Kyuseok Kim, MD         
Sub-Investigator: Sung-Bum Kang, MD         
Sub-Investigator: Young Hoon Kim, MD         
Sub-Investigator: Kyoung Ho Lee, MD         
Sub-Investigator: Joonghee Kim, MD         
Sub-Investigator: Chanjong Park, MD         
Sub-Investigator: Jae Hyuk Lee, MD         
Sub-Investigator: Hye Seung Lee, MD         
Sub-Investigator: Bon Seung Gu, RT         
Sponsors and Collaborators
Kyoung Ho Lee, MD
Ministry of Health & Welfare, Korea
Seoul National University Bundang Hospital
Dasol Life Science Inc.
Investigators
Study Chair: Kyoung Ho Lee, MD Seoul National University Bundang Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyoung Ho Lee, MD, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01925014     History of Changes
Other Study ID Numbers: LOCAT
Study First Received: August 15, 2013
Last Updated: December 22, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Appendectomy
Appendicitis
False Positive Reactions
Humans
Radiation Dosage
Tomography, X-Ray Computed
Young Adult

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014