UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014231 |
|---|---|
| Receipt number | R000016577 |
| Scientific Title | Japan multi-study:Efficacy of endoscopic balloon dialation to stricture using double-balloon endoscope with forceps channel diameter 3.2mm |
| Date of disclosure of the study information | 2014/06/30 |
| Last modified on | 2015/10/26 11:23:31 |
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Basic information
Public title
Japan multi-study:Efficacy of endoscopic balloon dialation to stricture using double-balloon endoscope with forceps channel diameter 3.2mm
Acronym
Japan DBE Study
Scientific Title
Japan multi-study:Efficacy of endoscopic balloon dialation to stricture using double-balloon endoscope with forceps channel diameter 3.2mm
Scientific Title:Acronym
Japan DBE Study
Region
| Japan |
Condition
Condition
Crohn's Disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of endoscopic balloon dialation to stricture using double-balloon endoscope with forceps channel diameter 3.2mm
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Propriety for endoscopic balloon dilation for small bowel strictures
Key secondary outcomes
1.Difficulty of balloon catheter insertion.
2.Check of Adverse event and it's Contents.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic balloon dilation using balloon assisted enteroscopy are performed for eligible small bowel stricture of patients.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.More than 20 years old and less than 75 years old
2.causing obstructive symptoms
3.more than 5cm in length of stricture
4.There are no following conditions in strictures.
1)without fistula or abssess
2)without deep ulcer
3)without severe curvature
Key exclusion criteria
1. acute abdomen
2. severe inflammation
3. pregnant woman
4. poor general condition patients who has risk for performing endoscopy such as ileus perforation of intestine pancreatitis respiratory disorder heart failure acquired hemophilia intestinal stricture large ulcer large tumor
5. ongoing anti coagulation therapy or anti platelet therapy
6. intolerance of polyethylene glycol only for transanal approach
7. patient who experienced entry of this study
8. patient who is judged to be unsuitable for this clinical trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Matsui |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1 Zokumyoin Chikushino Fukuoka
TEL
092-921-1011
matsui@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihito Hirai |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1 Zokumyoin Chikushino Fukuoka
TEL
092-921-1011
Homepage URL
fuhirai@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
FUJIILM Corporation
Organization
Division
Category of Funding Organization
Profit 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
自治医科大学（栃木県）、日本医科大学（東京都）、名古屋大学（愛知県）、広島大学（広島県）、福岡大学筑紫病院（福岡県）、九州大学（福岡県）、岩手医科大学（岩手県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | 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
| 2013 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 11 | Day |
Last modified on
| 2015 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016577
