Diagnostic accuracy of low dose polyethylene glycol (PEG) based fecal tagging computed tomography colonography (CTC) for the detection of colorectal neoplasia in patients with positive fecal immunochemical test
- Conditions
- colorectal cancer, colorectal polyp
- Registration Number
- JPRN-UMIN000006665
- Lead Sponsor
- Department od Medical Division of Radiology, Jichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
1) fecal immunochemical test positive.
2) Major functions of organs of the subjects are in a good condition.
3) Aged 40 years or older.
4) Signed informed consent forms are obtained by the patients.
1) Known colorectal polyps or cancers at any site at the time of enrollment.
2) Patients with inflammatory bowel disease.
3) Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
4) Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
5) Previous colorectal surgery.
6) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
7) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
8) Possibility of pregnancy.
9) Optical colonoscopy or barium enema carried out within the last 3 years.
10) Patients with psychological conditions that contraindicate colonoscopy or make them irrelevant to participate in the trial.
11) Claustrophobia.
12) Iodine hypersensitivity.
13) Severe thyroid disease.
14) Severe deafness.
15) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ow dose polyethylene glycol (PEG) based fecal tagging CTC vs. optical colonoscopy. Detection performance and accuracy of colorectal polyps (at least 6 mm in diameter) and colorectal cancer.
- Secondary Outcome Measures
Name Time Method Comparative adherence of patients to CTC and optical colonoscopy. <br>Frequency and nature of any adverse events.