Unique ID issued by UMIN | UMIN000003740 |
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Receipt number | R000004505 |
Scientific Title | Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia. |
Date of disclosure of the study information | 2010/07/01 |
Last modified on | 2013/06/13 23:13:37 |
Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia.
Prospective analysis of NBI-ME for colorectal dysplasia
Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia.
Prospective analysis of NBI-ME for colorectal dysplasia
Japan |
Colorectal neoplasm
Gastroenterology |
Malignancy
NO
To estimate the efficacy of Narrow band imaging with magnifying colonoscopy (NBI-ME) for the diagnosis of dysplasia of colorectal neoplasm.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Specificity of NBI-ME in accurate decision for low grade dysplasia.
Procedure time (insertion and observation), Diagnostic ability (sensitivity, specificity and accuracy) for high grade dysplasia, low grade dysplasia and non-neoplastic lesion using NBI-nonME and NBI-ME, Accurate clinical decision rate (resect and discard, resect and send and leave it in situ) using NBI-nonME and NBI-ME. Diagnostic accuracy according to the lesion size (<5mm, >6mm). Adverse events.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
Magnifying observation using magnifying endoscope.
20 | years-old | <= |
Not applicable |
Male and Female
Patients who are undergoing colonoscopy for positive fecal occult blood test, surveillance colonoscopy after endoscopic resection, and colonoscopic resection of colorectal neoplasms.
1)Patients who had previously undergone histological examination.
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 having 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
1-3-3, Nakamichi, Higashinari-ku, Osaka
06-6972-1181
1st name | |
Middle name | |
Last name | Yoji Takeuchi |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Gastrointestinal Oncology
1-3-3, Nakamichi, Higashinari-ku, Osaka
06-6972-1181
takeuti-yo@mc.pref.osaka.jp
Osaka Medical Center for Cancer and Cardiovascular Diseases
None
Self funding
None
NO
大阪府立成人病センター(大阪府)
2010 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2010 | Year | 06 | Month | 07 | Day |
2010 | Year | 07 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
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2012 | Year | 12 | Month | 01 | Day |
2010 | Year | 06 | Month | 12 | Day |
2013 | Year | 06 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004505
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