UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007852 |
|---|---|
| Receipt number | R000009253 |
| Scientific Title | Assessment of gastrointestinal motility in patients with chronic intestinal pseudo-obstruction using cine-MRI. |
| Date of disclosure of the study information | 2012/04/27 |
| Last modified on | 2020/11/02 09:10:30 |
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Basic information
Public title
Assessment of gastrointestinal motility in patients with chronic intestinal pseudo-obstruction using cine-MRI.
Acronym
Assessment of gastrointestinal motility in patients with chronic intestinal pseudo-obstruction using cine-MRI.
Scientific Title
Assessment of gastrointestinal motility in patients with chronic intestinal pseudo-obstruction using cine-MRI.
Scientific Title:Acronym
Assessment of gastrointestinal motility in patients with chronic intestinal pseudo-obstruction using cine-MRI.
Region
| Japan |
Condition
Condition
Chronic intestinal pseudo-obstruction (CIPO) and Irritable Bowel Syndrome (IBS)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the pathophysiology of CIPO and assess the usefulness of cine-MRI as a diagnostic method, comparing gastrointestinal motility in healthy people, IBS patients and CIPO patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean luminal diameter, contraction ratio, and contraction cycle, calculated from each image of cine-MRI.
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
1) Patients who meet the diagnostic criteria for CIPO proposed by Ministry of Health, Labor, and Welfare.
2) Patients who meet the Rome III criteria for the diagnosis of IBS.
3) Written informed consent was obtained.
Key exclusion criteria
1) Patients with organic digestive tract disease.
2) Patients with current or past history of malignant disease.
3) Patients with current other digestive diseases.
4) Subjects with contraindications to MRI.
5) Patients judged inappropriate for the trial by investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Yokohama City University School of Medicine
Division name
Gastroenterology Division
Zip code
236-0004
Address
3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL
045-787-2640
ohkuboh@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Ohkubo |
Organization
Yokohama City University School of Medicine
Division name
Gastroenterology Division
Zip code
236-0004
Address
3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL
045-787-2640
Homepage URL
ohkuboh@yokohama-cu.ac.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University School of Medicine, Yokohama, Japan
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants for Research on Intractable Diseases from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Odawara Municipal Hospital, Kanagawa
Itabashi Medical Association Hospital, Tokyo
Iwate Medical University, Iwate
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethical Committee for Medical and Health Research Involving Human Subjects
Address
5F Technocore Yokohama Kanazawa High-Tech Center 1-1-1 Fukuura, Kanazawa-ku, Yokohama City
Tel
045-370-7627
rinri@yokohama-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
小田原市立病院（神奈川県） Odawara Municipal Hospital, Kanagawa
板橋区医師会病院（東京都） Itabashi Medical Association Hospital, Tokyo
岩手医科大学（岩手県） Iwate Medical University, Iwate
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
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
| 2012 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cine-MRI is performed for healthy people and CIPO patients in order to understand the pathophysiology of CIPO and assess the usefulness of cine-MRI as an evaluation method for gastrointestinal motility.
Management information
Registered date
| 2012 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009253
