UMIN-CTR Clinical Trial

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
Email	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
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	Shiga University of Medical Science
Address	Seta-Tsukinowa, Otsu
Tel	077548-2544
Email	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
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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