UMIN-CTR Clinical Trial

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
Email	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
Email	ohkuboh@yokohama-cu.ac.jp

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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009253