UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003743 |
|---|---|
| Receipt number | R000004534 |
| Scientific Title | Effect of local steroid injection on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer - Preventing stomach deformation due to scar formation during the epithelial regeneration process |
| Date of disclosure of the study information | 2010/06/12 |
| Last modified on | 2013/12/05 21:59:20 |
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Basic information
Public title
Effect of local steroid injection on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer
- Preventing stomach deformation due to scar formation during the epithelial regeneration process
Acronym
Kenacort for the stomach
Scientific Title
Effect of local steroid injection on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer
- Preventing stomach deformation due to scar formation during the epithelial regeneration process
Scientific Title:Acronym
Kenacort for the stomach
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A prospective study on preventing stomach deformation by local injection of Kenacort following endoscopic submucosal dissection for gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance between marking clips placed on either side of the ulcer in the direction of short axis and length of the short axis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Local injection of 2 vials of Kenacort (50 mg/5 mL/V) on the day of endoscopic submucosal dissection (postoperative Day 0), Day 5, and Day 12
Interventions/Control_2
EGD were performed after ESD.
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
| 30 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with early gastric cancer scheduled for endoscopic submucosal dissection from whom informed consent was obtained
Key exclusion criteria
Post operative stomach
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | mori hirohito |
Organization
Kagawa university
Division name
Department of gastroenterology
Zip code
Address
1750-1 ooaza ikenobe miki town kida county kagawa prefecture
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagawa university
Division name
Department of gastroenterology
Zip code
Address
TEL
087-891-2156
Homepage URL
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
Funding Source
Organization
Kagawa university
Organization
Division
Category of Funding 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
| 2010 | Year | 06 | Month | 12 | 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 | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 06 | Month | 12 | Day |
Last modified on
| 2013 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004534
