UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005946 |
|---|---|
| Receipt number | R000007025 |
| Scientific Title | Efficacy and safety of endoscopic balloon dilation for small bowel strictures of patients with CD |
| Date of disclosure of the study information | 2011/07/07 |
| Last modified on | 2014/01/08 10:56:34 |
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Basic information
Public title
Efficacy and safety of endoscopic balloon dilation for small bowel strictures of patients with CD
Acronym
CDSEBD
Scientific Title
Efficacy and safety of endoscopic balloon dilation for small bowel strictures of patients with CD
Scientific Title:Acronym
CDSEBD
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Short term success rate of endoscopic balloon dilation
2 Rate of re dilation after initial treatment
3 Cumulative surgical free rate of after endoscopic balloon dilation
Key secondary outcomes
Adverse effects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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 with CD.
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CD patients who has small bowel stricture that meet inclusion criteria as follows
1causing obstructive symptoms
2more than 5cm in length of stricture
3without fistula or abssess
4without deep ulcer
5without 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
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Matsumoto |
Organization
Iwate Medical University
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
19-1 Uchimaru Morioka Iwate
TEL
019-651-5111
tmatsumo@iwate-med.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
syokaki@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2011 | Year | 07 | Month | 07 | 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
| 2011 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
| 2011 | Year | 07 | Month | 07 | Day |
Last modified on
| 2014 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007025
