UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002010 |
|---|---|
| Receipt number | R000002448 |
| Scientific Title | Chemically assisted endoscopic submucosal dissection by using mesna. |
| Date of disclosure of the study information | 2009/05/26 |
| Last modified on | 2009/05/26 17:52:07 |
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Basic information
Public title
Chemically assisted endoscopic submucosal dissection by using mesna.
Acronym
Chemically assisted ESD by using mesna.
Scientific Title
Chemically assisted endoscopic submucosal dissection by using mesna.
Scientific Title:Acronym
Chemically assisted ESD by using mesna.
Region
| Japan |
Condition
Condition
Early stage gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of mesna as a submucosal injectable solution for the endoscopic submucosal dissection technique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success
Key secondary outcomes
En bloc resection rate, Short and long term complication.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
ESD after submucosal injection of mesna.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Early stage gastric cancer cases suitable for ESD resection.
Key exclusion criteria
Patients with allergic history to
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of endoscopy
Zip code
Address
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University School of Medicine
Division name
Department of endoscopy
Zip code
Address
TEL
Homepage URL
kaz_sum@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine, Department of Endsocopy
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine, Department of Endsocopy
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2009 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 26 | Day |
Last modified on
| 2009 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002448
