UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019579 |
|---|---|
| Receipt number | R000022173 |
| Scientific Title | Effects of portal blood flow modification by B-RTO on the small intestine mucosa |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2015/10/30 21:29:54 |
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Basic information
Public title
Effects of portal blood flow modification by B-RTO on the small intestine mucosa
Acronym
Effect of B-RTO on the small intestine mucosa
Scientific Title
Effects of portal blood flow modification by B-RTO on the small intestine mucosa
Scientific Title:Acronym
Effect of B-RTO on the small intestine mucosa
Region
| Japan |
Condition
Condition
portal hypertensive enteropathy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed at assessing the effect of increase of portal blood pressure on the mucosa of the small intestine by comparing CE findings before and after B-RTO.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the capsule endoscope findings(red spot, angioectasia, varices, inflammatory like lesion) of before and 4-8 weeks after B-RTO.
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
Regardless of age or gender, inspection and image data of the small intestine capsule endoscopy before and after B-RTO is present.
Key exclusion criteria
nothing special
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Yamaguchi Univercity Hospital
Division name
Internal medicine I
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2241
has-333@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Yamaguchi Univercity Hospital
Division name
Internal medicine I
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2241
Homepage URL
has-333@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi Univercity Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi Univercity Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Patients:
Regardless of age or gendaer, inspection and image date of the small intestine capsule endoscopy befor and after B-RTO is present from September 1, 2010 to September 30, 2014
Outcomes:
Changes in the capsule endoscope findings (red spot, angioectasia, varices and inflammatory like lesion)
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2015 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022173
| 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 |
