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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007852
Receipt No. 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 2012/11/05

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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
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL 045-787-2640
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Ohkubo
Organization Yokohama City University School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL 045-787-2640
Homepage URL
Email

Sponsor
Institute Gastroenterology Division, Yokohama City University School of Medicine, Yokohama, Japan
Institute
Department

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
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
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 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 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
2012 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
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
2012 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009253

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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