Unique ID issued by UMIN | UMIN000005085 |
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Receipt number | R000006045 |
Scientific Title | Magnifying chromoscopic colonoscopy versus endoscopic ultrasonography to predict depth of invasion for early colorectal cancer |
Date of disclosure of the study information | 2011/02/16 |
Last modified on | 2014/01/18 01:39:14 |
Magnifying chromoscopic colonoscopy versus endoscopic ultrasonography to predict depth of invasion for early colorectal cancer
Magnifying colonoscopy vs. EUS to predict depth of invasion for early colorectal cancer
Magnifying chromoscopic colonoscopy versus endoscopic ultrasonography to predict depth of invasion for early colorectal cancer
Magnifying colonoscopy vs. EUS to predict depth of invasion for early colorectal cancer
Japan |
Patients with early colorectal cancer
Gastroenterology |
Malignancy
NO
To compare accuracy of the invasion depth for early colorectal cancer between magnifying chromoscopic colonoscopy (MC) and EUS
Efficacy
Confirmatory
Accuracy rate for invasion depth of early colorectal cancer by MC and EUS
Sensitivity and specificity for deep submucosal invasion, Observation time, Accuracy rate betweeen MC in A group and EUS in B group, Accuracy rate in each group between MC and EUS
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
No treatment
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Diagnosis
Device,equipment |
"A group: MC followed by EUS" for diagnosis of invasion depth
From February 2011 to December 2013
"B group: EUS followed by MC" for diagnosis of invasion depth
From February 2011 to December 2013
20 | years-old | <= |
90 | years-old | >= |
Male and Female
1.Histologically confirmed adenocarcinoma
2.Early colorectal cancer with flat type
3.Less than 4cm in size
4.20 years old =< age =< 90 years old
5.PS:0-2
6.Written informed consent
1.Patients with strong anticoagulant therapy
2.Severe heart, lung and renal dysfunction
3.Severe constipation
4.Weak patients who can not be treated by endoscopy or surgery
5.Investigator's decision
70
1st name | |
Middle name | |
Last name | Shimura Takaya |
Nagoya City University Graduate School of Medical Sciences
Department of Gastroenterology and Metabolism
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
052-853-8211
1st name | |
Middle name | |
Last name | Shimura Takaya |
Nagoya City University Graduate School of Medical Sciences
Department of Gastroenterology and Metabolism
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
052-853-8211
Nagoya City University Graduate School of Medical Sciences
None
Self funding
Nagoya Daini Red Cross Hospital
Chukyo Hospital
Gifu Prefectural Tajimi Hospital
Nagoya Memorial Hospital
kasugai Municipal Hospital
NO
名古屋市立大学病院(愛知県)、名古屋第二赤十字病院(愛知県)、社会保険中京病院(愛知県)、岐阜県立多治見病院(岐阜県)、名古屋記念病院(愛知県)、春日井市民病院(愛知県)
2011 | Year | 02 | Month | 16 | Day |
Published
http://www.sciencedirect.com/science/article/pii/S1542356513010343
MC and EUS each measured the depth of lesion invasion with 71.2% accuracy (correctly for 47 of 66 lesions).
MC and EUS are equally accurate in estimating the invasion depth of early stage CRC lesions.
Completed
2011 | Year | 01 | Month | 25 | Day |
2011 | Year | 02 | Month | 01 | Day |
2013 | Year | 01 | Month | 31 | Day |
2013 | Year | 02 | Month | 28 | Day |
2013 | Year | 02 | Month | 28 | Day |
2013 | Year | 03 | Month | 21 | Day |
2011 | Year | 02 | Month | 15 | Day |
2014 | Year | 01 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006045
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