UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011250 |
|---|---|
| Receipt number | R000013186 |
| Scientific Title | Prospective controlled study comparing balloon-assisted entroscopy and MR enterography for small bowel lesion in patients with Crohn's disease. |
| Date of disclosure of the study information | 2013/07/23 |
| Last modified on | 2024/03/31 23:53:36 |
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Basic information
Public title
Prospective controlled study comparing balloon-assisted entroscopy and MR enterography for small bowel lesion in patients with Crohn's disease.
Acronym
Progress Study
Scientific Title
Prospective controlled study comparing balloon-assisted entroscopy and MR enterography for small bowel lesion in patients with Crohn's disease.
Scientific Title:Acronym
Progress Study
Region
| Japan |
Condition
Condition
Crohn's disease patient with small bowel involvement
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detectability for small bowel lesion in patients with Crohn's disease by balloon-assisted enteroscopy comparison with MR enterography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Detection rate for small bowel lesion in patients with Crohn's disease by balloon-assisted enteroscopy comparison with MR enterography.
Key secondary outcomes
1) Detectability for transmural or extraluminal small bowel lesion in patients with Crohn's disease by MR enterography.
2) Detectability for small bowel stricture in patients with Crohn's disease by balloon-assisted enteroscopy and MR enterography.
3) Correlativity for enteroscopy score and MR enterography score.
4) Comparison with the findings of imaging modality (balloon-assisted enteroscopy, MR enterography) and disease activity index, CRP or fecal calprotectin.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
balloon-assisted enteroscopy
Interventions/Control_2
MR enterography
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Crohn's disease patient with small bowel involvement.
Key exclusion criteria
1) patients under 15 years of age.
2) patients with short bowel syndrome.
3) patients after (sub)total colectomy.
4) patients who have stoma.
5) claustrophobic patient.
6) patient with cardiac pacemaker.
7) patient with contraindications to MRI.
8) patients with allergy history for gadolinium contrast agent.
9) bronchial asthma patient.
10) patients with severe renal dysfunction.
11) patient with intestinal obstruction.
12) Patients who are not suitable for entry in this study by judged with physician.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka City University
Division name
Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
kenjiw1779@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka City University
Division name
Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
Homepage URL
kenjiw1779@gmail.com
Sponsor or person
Institute
Research on Health and Labor Sciences Research Grants for Research on Intractable Diseases from the Ministry of Health, Labor and Welfare, Japan
Institute
Department
Personal name
Funding Source
Organization
Research Grants for Research on Intractable Diseases from the Ministry of Health, Labor and Welfare, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka City University, Graduate School of Medicine
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
Tel
06-6645-3435
ethics@med.osaka-cu.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
東邦大学医療センター佐倉病院内科、自治医科大学消化器内科・放射線科、福岡大学筑紫病院消化器内科、慶應義塾大学医学部消化器内科、東京医科歯科大学消化器病態学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 23 | 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
| 2013 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 23 | 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
| 2013 | Year | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013186
