UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017537 |
|---|---|
| Receipt number | R000020323 |
| Scientific Title | Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2015/05/13 10:46:04 |
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Basic information
Public title
Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Acronym
Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Scientific Title
Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Scientific Title:Acronym
Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Region
| Japan |
Condition
Condition
Gastric neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic gastric submucosal dissection examined the factors that affect the healing after (ESD) artificial ulcer
Basic objectives2
Others
Basic objectives -Others
This study is to observe the healing process of the artificial ulcer after ESD to target the ESD enforcement patient to stomach tumor esophagus, stomach, duodenum by endoscopy (EGD).
The size of the artificial ulcer after ESD enforcement (ulcer size (length and breadth: mm)) are measured, then the appropriate EGD enforcement when it is determined that it is necessary to the attending physician within the normal practice range, of ulcer bottom the size of the measurement and I do healing judgment of therapy after ulcer.
The patient's background in healing artificial ulcer to consider whether there is an influence of (age, gender, medical history, height, weight, BMI, site of the artificial ulcer, size, such as the type of antacid used).
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction ratio of ESD after artificial ulcer, state of healing
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient stomach ESD enforcement
Key exclusion criteria
Patients who became a surgery after ESD
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Sasaki |
Organization
Aichi Medical University
Division name
Gastroenterology
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan
TEL
0561-62-3311
shimozato.akihiro.274@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Shimozato |
Organization
Aichi Medical University
Division name
Gastroenterology
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan
TEL
0561-62-3311
Homepage URL
shimozato.akihiro.274@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
愛知医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
age, sex, medical history, height, weight, BMI, the site of an artificial ulcer size, the type of antacids
Management information
Registered date
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020323
