UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009000 |
|---|---|
| Receipt number | R000010560 |
| Scientific Title | Efficacy of sodium alginate as an endoscopic submucosal injectant during endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2012/09/28 |
| Last modified on | 2013/10/01 08:52:01 |
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Basic information
Public title
Efficacy of sodium alginate as an endoscopic submucosal injectant during endoscopic submucosal dissection.
Acronym
Efficacy of sodium alginate as an endoscopic submucosal injectant during endoscopic submucosal dissection.
Scientific Title
Efficacy of sodium alginate as an endoscopic submucosal injectant during endoscopic submucosal dissection.
Scientific Title:Acronym
Efficacy of sodium alginate as an endoscopic submucosal injectant during endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to confirm therapeutic usefulness of sodium alginate as an endoscopic submucosal injectant during endoscopic submucosal dissection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event
Key secondary outcomes
operation time, en bloc resection rate, recurrence rate, complication, pathological curative resection rate, healing process of gastric ulcer due to endoscopic submucosal dissection, laboratory data
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 |
Interventions/Control_1
sodium alginate as an endoscopic submucosal injectant during endoscopic submucosal dissection.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Early gastric cancer which can be treated by endoscopic submucosal dissection according to third edition of Japanese gastric cancer treatment guidelines 2010.
Key exclusion criteria
Case with lymph node metastasis or distant metastasis.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Inomata |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Oita 879-5593, Japan
TEL
097-586-5843
geka1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Kusano |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Oita 879-5593, Japan
TEL
097-586-5843
Homepage URL
kusanot@oita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
KYOSEI PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 09 | Month | 28 | 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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 28 | Day |
Last modified on
| 2013 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
