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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
| National Research Foundation of Korea | OTHER |
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The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.
Acute appendicitis is a very common disease with the lifetime incidence of 7%. Abdomen CT is an established first-line diagnostic test in patients suspected of having acute appendicitis. Since many individuals suspected of having acute appendicitis are young, with a mean age of 30 years, CT radiation is of particular concern.
The estimated lifetime attributable risk of death from cancer due to the radiation exposure of a single abdomen CT study is 2-7/10,000 for average adults ranging 20-40 years in age.
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the negative appendectomy rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose CT | Experimental |
| |
| Standard-dose CT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic CT | Radiation | 2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose)) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative Appendectomy | Number of participants with unnecessary appendectomies (removal of un-inflamed appendix) | 1 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Imaging Test(s) | Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis | 1 week after CT |
| Appendiceal Perforation | Number of participants with appendiceal perforation |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Dose | Radiation dose is measured in terms of dose-length product (mGy•cm) as displayed in the CT console. The "length" indicates the scan range. | 1 day after CT |
| Estimate of Carcinogenic Risk Induced by CT Radiation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoung Ho Lee, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Kyuseok Kim, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22533576 | Derived | 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. |
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None of the enrolled participants were excluded from the trial before assignment to group.
Dates of the recruitment period: September 2009 to January 2011 Types of location: an emergency department in an urban tertiary hospital in Korea
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-dose CT | Aimed to 2 mSv in an average patient |
| FG001 | Standard-dose CT | Aimed to 8 mSv in an average patient |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CT Examination |
| |||||||||||||
| Clinical Outcomes |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-dose CT | Aimed to 2 mSv in an average patient |
| BG001 | Standard-dose CT | Aimed to 8 mSv in an average patient |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Negative Appendectomy | Number of participants with unnecessary appendectomies (removal of un-inflamed appendix) | Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis. | Posted | Number | participants | 1 week after surgery |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-dose CT | Aimed to 2 mSv in an average patient |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
In this diagnostic trial, participants have a variety of abdominal diseases. Events with CTCAE v4 Grade 2 or less are not considered reportable according to the Study Protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyoung Ho Lee | Seoul National University Bundang Hospital | 82-31-787-7607 | kholeemail@gmail.com |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| Diagnostic CT | Radiation | 8 mSv in an average patient (Standard-dose CT) |
|
|
| 1 week after surgery |
| Interval Between CT and Appendectomy | Time interval between the CT acquisition and non-incidental appendectomy | 1 day after surgery |
| Interval Between CT and Discharge Without Surgery | Time interval between the CT acquisition and discharge without surgery | 3 months after CT |
| Interval From CT to Discharge After Appendectomy | Time interval between the CT acquisition and discharge after appendectomy | 3 months after CT |
| Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis | Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended. Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence. | 3 months after CT |
| Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis | Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended. Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence. | 3 months after CT |
| Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis. | True positive: Perforation was rated as present in CT report and confirmed as present. False positive: Perforation was rated as present in CT report and confirmed as absent. True negative: Perforation was rated as absent in CT report and confirmed as absent. False negative: Perforation was rated as absent in CT report and confirmed as present. The data are used to calculate sensitivity and specificity. | 3 months after CT |
| Visualization of the Normal Appendix | Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized | 3 months after CT |
Age- and sex-specific carcinogenic risk induced by CT radiation. This is not an actual measurement but an estimate of the stochastic risk, based on assumption and calculation from radiation dose used.
| 1 day after CT |
| NOT COMPLETED |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Body mass index | Number | kg/m^2 |
|
| White blood cell | Median | Inter-Quartile Range | x10^3/mm^3 |
|
| Segmented neutrophil | Median | Inter-Quartile Range | Percentage of peripheral Leukocytes |
|
| C-reactive protein | Median | Inter-Quartile Range | mg/dL |
|
| CT scanner | Number | participants |
|
| Radiologist | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Additional Imaging Test(s) | Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis | All participants included in outcome analyses. Intention to treat. Complete case analysis. | Posted | Number | participants | 1 week after CT |
|
|
|
| Secondary | Appendiceal Perforation | Number of participants with appendiceal perforation | Participants confirmed to have appendicitis. Intention to treat. Complete case analysis. | Posted | Number | participants | 1 week after surgery |
|
|
|
| Secondary | Interval Between CT and Appendectomy | Time interval between the CT acquisition and non-incidental appendectomy | Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis. | Posted | Median | Inter-Quartile Range | hr | 1 day after surgery |
|
|
|
| Secondary | Interval Between CT and Discharge Without Surgery | Time interval between the CT acquisition and discharge without surgery | Participants who did not undergo surgery. Intention to treat. Complete case analysis. | Posted | Median | Inter-Quartile Range | hr | 3 months after CT |
|
|
|
| Secondary | Interval From CT to Discharge After Appendectomy | Time interval between the CT acquisition and discharge after appendectomy | Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis. | Posted | Median | Inter-Quartile Range | day | 3 months after CT |
|
|
|
| Secondary | Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis | Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended. Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence. | Participants confirmed to have appendicitis. Intention to treat. Complete case analysis. There can be missing data if CT report was not made following predefined structured format. | Posted | Number | participants | 3 months after CT |
|
|
|
| Secondary | Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis | Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended. Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence. | Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis. There can be missing data if CT report was not made following predefined structured format. | Posted | Number | participants | 3 months after CT |
|
|
|
| Other Pre-specified | Radiation Dose | Radiation dose is measured in terms of dose-length product (mGy•cm) as displayed in the CT console. The "length" indicates the scan range. | All participants who underwent CT. Intention to treat. Complete case analysis. | Posted | Median | Inter-Quartile Range | mGy•cm | 1 day after CT |
|
|
|
| Other Pre-specified | Estimate of Carcinogenic Risk Induced by CT Radiation | Age- and sex-specific carcinogenic risk induced by CT radiation. This is not an actual measurement but an estimate of the stochastic risk, based on assumption and calculation from radiation dose used. | Not Posted | Number | Event per 100,000 persons | 1 day after CT |
| Secondary | Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis. | True positive: Perforation was rated as present in CT report and confirmed as present. False positive: Perforation was rated as present in CT report and confirmed as absent. True negative: Perforation was rated as absent in CT report and confirmed as absent. False negative: Perforation was rated as absent in CT report and confirmed as present. The data are used to calculate sensitivity and specificity. | Participants confirmed to have appendicitis. Intention to treat. Complete case analysis. There can be missing data if CT report was not made following predefined structured format. | Posted | Number | participants | 3 months after CT |
|
|
|
| Secondary | Visualization of the Normal Appendix | Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized | Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis. There can be missing data if CT report was not made following predefined structured format. | Posted | Number | participants | 3 months after CT |
|
|
|
| 13 |
| 444 |
| 1 |
| 444 |
| EG001 | Standard-dose CT | Aimed to 8 mSv in an average patient | 11 | 447 | 1 | 447 |
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Missing |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Missing |
|
| True negative |
|
| False negative |
|
| Missing |
|
| Grade 2 |
|
| Missing |
|