Unique ID issued by UMIN | UMIN000003786 |
---|---|
Receipt number | R000004580 |
Scientific Title | A randomized comparison of chemically assisted ESD with submucosal injection of mesna and standard ESD. |
Date of disclosure of the study information | 2010/06/21 |
Last modified on | 2012/11/09 14:52:42 |
A randomized comparison of chemically assisted ESD with submucosal injection of mesna and standard ESD.
A RCT of CA-ESD using mesna and standard ESD.
A randomized comparison of chemically assisted ESD with submucosal injection of mesna and standard ESD.
A RCT of CA-ESD using mesna and standard ESD.
Japan |
Early gastric cancer
Gastroenterology |
Malignancy
NO
ESD has enabled us to radically excise superficial early stage gastric cancer. However, ESD carries higher risk of complications due to the technical difficulty of endoscopic dissection of the submucosal layer. Preceding animal and clinical pilot studies demonstrated that a mucolytic agent, so called mesna could chemically soften the submucosal tissue plane and facilitated the submucosal dissection process in ESD. In order to clarify the advantage of this chemically assisted ESD technique over standard procedures, we will compare outcomes of chemically assisted ESD and standard ESD.
Safety,Efficacy
Procedural time
Procedural success rate
En bloc resection rate
Complication and side effect rates
The healing process of post therapeutic ulceration
Histological analysis of chemical effect on sampled specimens
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Maneuver |
Using mesna as a submucosal injection solution
Using saline as a submucosal injection solution
Not applicable |
Not applicable |
Male and Female
Gastric neoplasias with indications of ESD
History of hypersensitivity to mesna and women who were pregnant, lactating, or hoping to become pregnant during this study period
100
1st name | |
Middle name | |
Last name | Kazuki Sumiyama |
The Jikei University School of Medicine
Department of Endoscopy
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo 105-8461, Japan
1st name | |
Middle name | |
Last name |
The Jikei University School of Medicine
Department of Endoscopy
kaz_sum@jikei.ac.jp
The Jikei University School of Medicine
Research fund of The Jikei University School of Medicine, Department of Endoscopy.
Self funding
NO
2010 | Year | 06 | Month | 21 | Day |
Unpublished
Enrolling by invitation
2010 | Year | 06 | Month | 21 | Day |
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 06 | Month | 19 | Day |
2012 | Year | 11 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004580
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |