Unique ID issued by UMIN | UMIN000001473 |
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Receipt number | R000001762 |
Scientific Title | A prospective randomized controlled trial of autofluorescence imaging colonoscopy with transparent hood versus conventional colonoscopy for adenoma detection. |
Date of disclosure of the study information | 2008/11/01 |
Last modified on | 2010/11/02 13:14:36 |
A prospective randomized controlled trial of autofluorescence imaging colonoscopy with transparent hood versus conventional colonoscopy for adenoma detection.
AFI with Transparent hood Randomized Controlled Trial (ATRACT)
A prospective randomized controlled trial of autofluorescence imaging colonoscopy with transparent hood versus conventional colonoscopy for adenoma detection.
AFI with Transparent hood Randomized Controlled Trial (ATRACT)
Japan |
Colorectal neoplasm
Gastroenterology |
Malignancy
NO
To estimate the improvement of colorectal neoplasm detection using autofluorescence imaging colonoscopy with transparent hood.
Efficacy
Confirmatory
Pragmatic
Phase II
Neoplasm detection rate
Total number of cancers in both group.
Total number of depressed/flat/sessile lesions. Total number of hyperplastic polyp. Total number of adenomas less than 5mm. Right-sided versus left-sided location. Total number of adenomas larger than 1cm. Total number of patients with polyps. Total number of patient with adenoma less than 5mm. Procedure time (intubation time and observation time). Adverse event.
Interventional
Factorial
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
4
Diagnosis
Device,equipment |
White light imaging without hood group
White light imaging with hood group
Autofluorescence imaging without hood group
Autofluorescence imaging with hood group
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients who are undergoing screening colonoscopy for positive fecal occult blood examination, or surveillance colonoscopy after endoscopic resection for colorectal neoplasm.
2)Patients who provided written informed consent
1)Patients who had previously undergone major surgery.
2)Patients with open bleeding or symptoms suspected colonic stenosis.
3)Patients with inflammatory bowel disease, familial polyposis and known colon neoplasm.
4)Patients who are receiving anticoaglant medication or bleeding tendency.
5)Patients with severe organ failure.
6)Patients without informed consent.
7)Patients who are regarded in-eligible by the doctor who participates in this study.
550
1st name | |
Middle name | |
Last name | Yoji Takeuchi |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Gastrointestinal Oncology
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
06-6972-1181
1st name | |
Middle name | |
Last name | Yoji Takeuchi |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Gastrointestinal Oncology
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
06-6972-1181
takeuti-yo@mc.pref.osaka.jp
Osaka Medical Center for Cancer and Cardiovascular Diseases
None
Self funding
NO
2008 | Year | 11 | Month | 01 | Day |
Published
http://www.giejournal.org/current
Neoplasm detection rate (95% confidence interval) in the AFI+TH group was significantly higher than in the WLI alone group (1.96 [1.50-2.43] vs 1.19 [0.93-1.44]; P = .023, Tukey-Kramer multiple comparison test). Relative detection ratios (95% confidence interval) for polypoid neoplasms based on Poisson regression model were significantly increased by mounting a TH (1.69 [1.34-2.12], P < .001), and relative detection ratios for flat neoplasms were significantly increased by AFI observation (1.83 [1.24-2.71], P = .002).
Completed
2008 | Year | 10 | Month | 24 | Day |
2008 | Year | 11 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 01 | Month | 01 | Day |
2010 | Year | 02 | Month | 01 | Day |
2008 | Year | 11 | Month | 01 | Day |
2010 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001762
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