UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011489 |
|---|---|
| Receipt number | R000013444 |
| Scientific Title | The efficacy and safety of endoscopic submucosal dissection using sodium carboxymethylcellulose as a submucosal injection for gastric cancer |
| Date of disclosure of the study information | 2013/08/14 |
| Last modified on | 2013/08/14 16:19:06 |
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Basic information
Public title
The efficacy and safety of endoscopic submucosal dissection using sodium carboxymethylcellulose as a submucosal injection for gastric cancer
Acronym
ESD-SCMC for gastric cancer
Scientific Title
The efficacy and safety of endoscopic submucosal dissection using sodium carboxymethylcellulose as a submucosal injection for gastric cancer
Scientific Title:Acronym
ESD-SCMC for gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine the efficacy and safety of ESD using SCMC (ESD-SCMC) for gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
en bloc resection rate
Key secondary outcomes
complete resection rate, procedual time, complication, bleeding after SCMC injection
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
submucosal SCMC injection
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a differentiated-type adenocarcinoma without ulceration regardless of size; an intramucosal differentiated-type adenocarcinoma with ulceration with a diameter of 3 cm or less; and an intramucosal undifferentiated-type adenocarcinoma without ulceration with a diameter of 2 cm or less.
Key exclusion criteria
These were selected as the target cases, while those cases that did not meet the criteria or those where the patient did not give written consent were eliminated from consideration.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsutoshi Obara |
Organization
Fukushima Medical University Hospital
Division name
Department of Endoscopy
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1583
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuto Hikichi |
Organization
Fukushima Medical University Hospital
Division name
Department of Endoscopy
Zip code
Address
TEL
Homepage URL
takuto@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
福島県立医科大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 14 | 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
| 2010 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | 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
| 2013 | Year | 08 | Month | 14 | Day |
Last modified on
| 2013 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013444
| 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 |
