UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016095 |
|---|---|
| Receipt number | R000018408 |
| Scientific Title | Factors affects ulcer healing after gastric endoscopic submucosal dissection |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2016/08/19 14:34:55 |
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Basic information
Public title
Factors affects ulcer healing after gastric endoscopic submucosal dissection
Acronym
Factors affects ulcer healing after gastric endoscopic submucosal dissection
Scientific Title
Factors affects ulcer healing after gastric endoscopic submucosal dissection
Scientific Title:Acronym
Factors affects ulcer healing after gastric endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
superficial gastric neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the factor affecting ulcer healing after gastric-ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ulcer reduction rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1.cancers referring to the expanded criteria
2.cancers excluded by the above criteria that were treated at patient's request
3. gastric adenomas that were difficult to distinguish from cancer.
Key exclusion criteria
(1) experienced delayed bleeding, (2) required additional surgery, (3) had previous surgery, (4) were lost to follow-up, (5) required steroid injection to prevent stenosis, or (6) had poor compliance with oral administration of the study drugs (> 20%).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Horikawa |
Organization
Hiraka General Hospital
Division name
Gastroenterology
Zip code
Address
Maego 3-1, Yatsukuchi, Yokote city
TEL
0182-32-5121
horikawa_01@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Horikawa |
Organization
Hiraka General Hospital
Division name
Gastroenterology
Zip code
Address
Maego 3-1, Yatsukuchi, Yokote city
TEL
0182-32-5121
Homepage URL
horikawa_01@me.com
Sponsor or person
Institute
Hiraka General Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
measuring ulcer size at endoscopy on 4W/8W after ESD
Management information
Registered date
| 2014 | Year | 12 | Month | 31 | Day |
Last modified on
| 2016 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018408
