CT Carcinogenic Risk in Patients With Appendicitis

Appendicitis Clinical Trial

Official title:

Carcinogenic Risk of CT in Patients With Appendicitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03776435
• Other study ID #: AppyCTcancer
• Status: Recruiting
• Start date: January 15, 2018
• Est. completion date: May 15, 2021

Study information

• Verified date: February 2020
• Source: Seoul National University Bundang Hospital
• Contact: Ji Hoon Park, MD
• Phone: 82-10-8526-0650
• Email: pjihoon79[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare the incidence rate of leukemia between CT-exposed and CT-unexposed group in patients who underwent appendectomy in South Korea.

Description:

South Korea has a single-payer healthcare system, administered by National Health Insurance Service (NHIS). As healthcare providers in South Korea need to claim reimbursement to NHIS for the vast majority of diagnostic and therapeutic procedures, the NHIS database enabled us to construct a large cohort who did or did not undergo CT for appendicitis. The purpose of this study is to compare the incidence rate of cancer between CT-exposed and CT-unexposed group in patients who underwent appendectomy in South Korea.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000000
• Est. completion date: May 15, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients will be entered in the cohort on the date of appendectomy under the diagnosis of appendicitis

Exclusion Criteria:

• (a) patients who had a cancer diagnosis before the date of appendectomy,

• (b) those who had prior experience of CT examination more than 7 days before appendectomy,

• (c) those who had syndromes or diseases predisposing cancers,

• (d) those whose diagnosis was changed to appendiceal cancer and

• (e) those whose follow-up duration was shorter than a lag period.

Related Conditions & MeSH terms

• Appendicitis
• Carcinogenesis
• Computed Tomography
• Radiation Exposure

Intervention

Radiation:
• Abdomen CT
Patients are divided into CT-exposed or unexposed group according to the presence of claims codes of abdominopelvic CT conducted within seven days before and after appendectomy. The seven-day threshold is arbitrarily determined considering the delay in the diagnosis of appendicitis and the postoperative examination for surgical complication.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bunadang Hospital	Seongnam-Si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity analysis	Various lag periods will be applied for the outcomes.	Cancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)
Other	Subgroup analysis by subsequent CT scans conducted more than 7 days after appendectomy	IRR in patients who underwent CT after appendectomy IRR in patients who did not undergo CT after appendectomy	CT undergone more than 7 days after appendectomy will be counted.
Other	Subgroup analysis	by age and sex	Cancer occurrence after a lag period (2 years)
Primary	Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system	Hematologic malignancies are categorized into lymphomas, multiple myeloma, leukemias, myelodysplasia and others using ICD-10 codes.	Cancer occurrence after a lag period (2 years)
Secondary	Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs	age and sex-standardized IRRs for malignancies of abdominal organs for CT-exposed versus unexposed patients.	Cancer occurrence after a lag period (2 years)
Secondary	Age and sex-standardized incidence rate ratio (IRR) for all cancers	age and sex-standardized IRRs for all cancers for CT-exposed versus unexposed patients.	Cancer occurrence after a lag period (2 years)