UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of diagnosis and treatment of inflammatory bowel diseases.
Title of the study (Brief title)	Evaluation of diagnosis and treatment of inflammatory bowel diseases.
Region	Japan

Condition
Condition	Inflammatory bowel diseases
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Upper and lower gastrointestinal endoscopy, small intestine endoscopy and capsule endoscopy are essential for the diagnosis of IBD. Gastrointestinal contrast studies also become an important diagnostic tool. Findings of endoscopy and gastrointestinal contrast study, pathological findings obtained by biopsy and clinical symptoms make definitive diagnosis of IBD. In recent years, fecal occult blood test and fecal calprotectin are used as a biomarker of intestinal inflammation, which is an index of activity of the diseases. The clinical severity of abdominal pain and diarrhea, the severity of the intestinal lesions obtained by endoscopy determine treatment of IBD patients. As a medical therapy, we can use amino salicylic acid, steroid, immunomodulator, immunosuppresant, biologics, cytapherasis, nutritional therapy and endoscopic balloon dilatation. Surgery is also chosen as surgical treatment. It is necessary to evaluate the accuracy of diagnosis and the usefulness of these therapy, and we should improve medical care of IBD patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	It is necessary to evaluate the accuracy of diagnosis and the usefulness of these therapy, and we should improve medical care of IBD patients.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	IBD patients who took examinations of endoscopy and received treatment in our hospital
Key exclusion criteria	IBD patients of whom we cannot track the subsequent clinical course
Target sample size	200

Research contact person
Name of lead principal investigator	Yoshiki Hirooka
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Address	65 Tsurumai-cho, Showa-ku, Nagoya city
TEL	052-744-2172
Email	hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person	Osamu Watanabe
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65 Tsurumai-cho, Showa-ku, Nagoya city
TEL	052-744-2172
Homepage URL
Email	osa-wata@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	No
Name of secondary funｄer(s)

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	2016 Year 03 Month 23 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 10 Day
Anticipated trial start date	2016 Year 03 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	observation study

Management information
Registered date	2016 Year 02 Month 09 Day
Last modified on	2017 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024181