UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of colon motility in patients with megacolon and slow transit constipation using cine-MRI
Title of the study (Brief title)	Assessment of colon motility using cine-MRI
Region	Japan

Condition
Condition	megacolon and slow tlansit constipation (STC)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To understand the pathophysiology of megacolon and STC, we will assess the usefulness of cine-MRI as a diagnostic method, comparing colon motility in healthy people.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
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 are diagnosed megacolon or STC from their symptom, X-rays, and CT scan. 2. 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	20

Research contact person
Name of lead principal investigator	Atsushi Nakajima
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL	045-787-2640
Email	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	Yumi Inoh
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL	045-787-2864
Homepage URL
Email	iyumi@yokohama-cu.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	小田原市立病院(神奈川)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	2014 Year 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 15 Day
Anticipated trial start date	2014 Year 06 Month 01 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	To understand the pathophisiology of megacolon and STC, we will assess the usefulness of cine-MRI as a diagnostic method, comparing colon motility in healthy people.

Management information
Registered date	2014 Year 06 Month 01 Day
Last modified on	2017 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016457