Unique ID issued by UMIN | UMIN000001302 |
---|---|
Receipt number | R000001579 |
Scientific Title | Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial. |
Date of disclosure of the study information | 2008/08/20 |
Last modified on | 2015/10/20 23:22:49 |
Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.
Device selection RCT in colorectal ESD.
Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.
Device selection RCT in colorectal ESD.
Japan |
colorectal epitherial neoplasm
Gastroenterology |
Malignancy
NO
To evaluate the efficacy of Flush knife compared with Flex knife in colorectal ESD.
Efficacy
Confirmatory
Pragmatic
Phase II
Procedure time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
2
Treatment
Device,equipment |
Flex knife group
Flush knife group
Not applicable |
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 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.
50
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
takeuti-yo@mc.pref.osaka.jp
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, Japan
06-6972-1181
takeuti-yo@mc.pref.osaka.jp
Osaka Medical Center for Cancer and Cardiovascular Diseases
None
Self funding
NO
2008 | Year | 08 | Month | 20 | Day |
Published
http://www.nature.com/ajg/journal/vaop/ncurrent/abs/ajg2009547a.html
Without increasing adverse events, the endo-knife with a water-jet function efficiently reduced the operation time of colorectal ESD in patients with large superficial neoplasms.
Completed
2008 | Year | 03 | Month | 31 | Day |
2008 | Year | 04 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 04 | Month | 01 | Day |
2009 | Year | 05 | Month | 01 | Day |
2008 | Year | 08 | Month | 06 | Day |
2015 | Year | 10 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001579
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |