Unique ID issued by UMIN | UMIN000020160 |
---|---|
Receipt number | R000023288 |
Scientific Title | Safety and efficacy under suuficient operation view using Endoscopic Ring Thread Technique(ERTT)of endoscopic submucosal dissection |
Date of disclosure of the study information | 2015/12/10 |
Last modified on | 2018/12/11 16:22:47 |
Safety and efficacy under suuficient operation view using Endoscopic Ring Thread Technique(ERTT)of endoscopic submucosal dissection
Safety and efficacy of ERTT
Safety and efficacy under suuficient operation view using Endoscopic Ring Thread Technique(ERTT)of endoscopic submucosal dissection
Safety and efficacy of ERTT
Japan |
Adenoma or early carcinoma of small intestine or colon
Medicine in general | Gastroenterology | Surgery in general |
Gastrointestinal surgery |
Malignancy
NO
Evaluate whether the ERTT during small intestine or colonic ESD reduce the complication such as bleeding or perforation under sufficient view created by ring thread
Safety,Efficacy
Confirmatory
The primary outcome was the dissected area per minute during ESD (DAn) (cm2/min)
1.Bleeding event during ESD
2.The procedure time of creating ERTT
3.Perforation rate
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
2
Treatment
Device,equipment | Other |
ERTT for adenoma or early small intestine or colonic carcinoma
Conventional ESD
20 | years-old | <= |
90 | years-old | > |
Male and Female
Patients who are going to be perfprmed ESD of adenoma or early carcinoma, and satisfied with the inclusion criteria of Japan Gastroenterological Endoscopy Society (JGES):Differentiated type within SM1 depth invasion, budding (G1), who are able to be appropriate indication for ESD
Patients who are recommended for operation
45
1st name | |
Middle name | |
Last name | Mori Hirohito |
Kagawa university
Department of Gastroenterology and Neurology
1750-1, Miki, Kida, Kagawa, Japan
087-891-1256
hiro4884@med.kagawa-u.ac.jp
1st name | |
Middle name | |
Last name | Hayashi Yukari |
Ehime Rousai Hospital
Medical Affairs Division
13-27, Minamikomatsubara, Niihama, Ehime 792-8550, Japan
0897-33-6191
ijikachou@ehimerosai.jp
Kagawa university
Ehime Rousai Hospital
Other
NO
愛媛労災病院(愛媛県),香川大学医学部(香川県)
2015 | Year | 12 | Month | 10 | Day |
Unpublished
Completed
2015 | Year | 12 | Month | 10 | Day |
2015 | Year | 12 | Month | 10 | Day |
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 10 | Month | 12 | Day |
2015 | Year | 12 | Month | 10 | Day |
2018 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023288
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |