UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009944 |
|---|---|
| Receipt number | R000011648 |
| Scientific Title | Clinical utility of double-balloon enteroscopy subsequent to negative capsule endoscopy for obscure gastrointestinal bleeding |
| Date of disclosure of the study information | 2013/02/04 |
| Last modified on | 2014/08/05 08:33:21 |
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Basic information
Public title
Clinical utility of double-balloon enteroscopy subsequent to negative capsule endoscopy for obscure gastrointestinal bleeding
Acronym
Clinical utility of subsequent double-balloon enteroscopy for obscure gastrointestinal bleeding
Scientific Title
Clinical utility of double-balloon enteroscopy subsequent to negative capsule endoscopy for obscure gastrointestinal bleeding
Scientific Title:Acronym
Clinical utility of subsequent double-balloon enteroscopy for obscure gastrointestinal bleeding
Region
| Japan |
Condition
Condition
obscure gastrointestinal bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical utility of subsequent DBE after negative CE for OGIB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Re-bleeeding 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
OGIB
Key exclusion criteria
Patients who underwent DBE before CE
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
043-222-7171
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN
TEL
043-226-2083
Homepage URL
araim-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
| 2013 | Year | 02 | Month | 04 | 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
Dig Endosc. 2014 Mar 13. doi: 10.1111/den.12257. [Epub ahead of print]
Predictive factor of re-bleeding after negative capsule endoscopy for obscure gastrointestinal bleeding: Over 1-year follow-up study.
Matsumura T1, Arai M, Saito K, Okimoto K, Saito M, Minemura S, Oyamada A, Maruoka D, Nakagawa T, Watabe H, Katsuno T, Yokosuka O.
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
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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
Restrospective analysis to clarify the clinical utility of subsequent DBE after negative CE for OGIB.
Management information
Registered date
| 2013 | Year | 02 | Month | 04 | Day |
Last modified on
| 2014 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011648
