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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028355
Receipt No. 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 2017/07/24

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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
Middle name
Last name Shigeki Bamba
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta-Tsukinowa, Otsu
TEL 0775482217
Email sb@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Bamba
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta-Tsukinowa, Otsu
TEL 0775482217
Homepage URL
Email sb@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 24 Day
Last follow-up date
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
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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