Unique ID issued by UMIN | UMIN000002812 |
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Receipt number | R000003395 |
Scientific Title | Efficacy of endoscope equipped with water-jet function for hemostasis of endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial. |
Date of disclosure of the study information | 2009/11/30 |
Last modified on | 2011/05/30 09:23:47 |
Efficacy of endoscope equipped with water-jet function for hemostasis of endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.
Efficacy of water-jet endoscope for colorectal ESD.
Efficacy of endoscope equipped with water-jet function for hemostasis of endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.
Efficacy of water-jet endoscope for colorectal ESD.
Japan |
colorectal epitherial neoplasm
Gastroenterology |
Malignancy
NO
To evaluate the efficacy of endoscope equipped with water-jet function for colorectal endoscopic submucosal dissection.
Efficacy
Confirmatory
Pragmatic
Phase II
total time to hemostasis
en bloc resection rate, complete resection rate, adverse events, total procedure time, bleeding time, endoscopic device changes, Coagrasper using times, preventive hemostasis times
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment |
non water-jet group
water-jet group
20 | years-old | <= |
Not applicable |
Male and Female
Intramucosal or minutes submucosal invaded (SM1) colorectal epitherial neoplasms which are larger than 20mm and smaller than 60mm.
1) SM massive invaded cancer
2) Lesions which are existed on anal canal or in cecum.
3) Patients with hematological abnormality.
4) Patients with severe organ failure
5) Patients without written informed consent
6) Lesions which were thought to be difficult to resect by ESD because of unstable positioning of colonoscope.
7) Others who were thought to be unsuitable by endoscopist.
90
1st name | |
Middle name | |
Last name | Yoji Takeuchi |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Gastrointestinal Oncology
3-3 Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
06-6972-1181
1st name | |
Middle name | |
Last name | Yoji Takechi |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Gastrointestinal Oncology
3-3 Nakamichi 1-chome, 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
大阪府立成人病センター(大阪府)
2009 | Year | 11 | Month | 30 | Day |
Unpublished
Completed
2009 | Year | 09 | Month | 10 | Day |
2009 | Year | 12 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2009 | Year | 11 | Month | 30 | Day |
2011 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003395
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