UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017351 |
|---|---|
| Receipt number | R000020137 |
| Scientific Title | Effect of exposure of HCl, bile acid nitric oxide on epithelial mucosal injury in Barrett's esophagus - a study using biopsy specimen- |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2015/04/30 18:22:57 |
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Basic information
Public title
Effect of exposure of HCl, bile acid nitric oxide on epithelial mucosal injury in Barrett's esophagus - a study using biopsy specimen-
Acronym
Effect of exposure of HCl, bile acid nitric oxide on epithelial mucosal injury in Barrett's esophagus
Scientific Title
Effect of exposure of HCl, bile acid nitric oxide on epithelial mucosal injury in Barrett's esophagus - a study using biopsy specimen-
Scientific Title:Acronym
Effect of exposure of HCl, bile acid nitric oxide on epithelial mucosal injury in Barrett's esophagus
Region
| Japan |
Condition
Condition
Barrett's esophagus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the responsiveness
of Barrett's epithelium and suquamous epithelium to ex vivo exposure to HCl, bile acid, and nitric oxide, using biopsy specimens from patients with Barrett's esophagus,
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of epithelial resistance and permeability in ex vivo chamber system in response to exposure of HCl, bile acid, and nitric oxide
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
taking endoscopic biopsy specimens
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
Patients with Barrett's esophagus
Key exclusion criteria
1. Taking antithrombotic drugs
2. Taking NSAIDs
3. bleeding tendancy
4. serious systematic diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iijima Katsunori |
Organization
Tohoku University Graduate Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aobaku, Sendai 980-8574, Japan
TEL
022-717-7171
kiijima@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iijima Katsunori |
Organization
Tohoku University Graduate Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aobaku, Sendai 980-8574, Japan
TEL
022-717-7171
Homepage URL
kiijima@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Graduate Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid
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
| 2016 | Year | 01 | 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 | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2015 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020137
