UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028355 |
|---|---|
| Receipt number | R000032452 |
| Scientific Title | Avoidance of surgery with endoscopic balloon dilation and pharmacotherapy in obstructive small bowel Crohn's disease: a retrospective Japanese multicenter study |
| Date of disclosure of the study information | 2017/07/24 |
| Last modified on | 2020/01/25 09:33:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Avoidance of surgery with endoscopic balloon dilation and pharmacotherapy in obstructive small bowel Crohn's disease: a retrospective Japanese multicenter study
Acronym
Symptomatic obstructive small bowel Crohn's disease and intestinal resection
Scientific Title
Avoidance of surgery with endoscopic balloon dilation and pharmacotherapy in obstructive small bowel Crohn's disease: a retrospective Japanese multicenter study
Scientific Title:Acronym
Symptomatic obstructive small bowel Crohn's disease and intestinal resection
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between symptomatic small intestinal stricture and intestinal resection of Crohn's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative intestinal resection rate after onset of symptomatic stenosis
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Crohn's disease patients with previous consultation from January 1, 2008 to March 31, 2017
(i) Among patients diagnosed with Crohn's disease, those who developed stenotic symptoms for the first time from January 1, 2008 through March 31, 2017.
(ii) Confirmation of gastrointestinal stricture is performed by balloon small intestine endoscopy, X-ray fluoroscopy, CT, capsule endoscopy examination, etc.
Key exclusion criteria
(i) Case in which intestinal resection is performed before symptomatic stenosis
(ii) Case diagnosed as adhesive ileus
(iii) Case with fistula
(iv) Patient who had an offer to refuse research cooperation
(v) In addition, when the doctor judges it as inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
0775482217
sb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
0775482217
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta-Tsukinowa, Otsu
Tel
077548-2544
hqeiyo@belle.shiga-med.ac.jp
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
| 2017 | Year | 07 | Month | 24 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2017 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032452
