UMIN-CTR Clinical Trial

Basic information
Public title	Difference in clinical features between idiopathic and secondary chronic intestinal pseudo-obstruction:A retrospective single center study
Acronym	Difference in clinical features between idiopathic and secondary chronic intestinal pseudo-obstruction
Scientific Title	Difference in clinical features between idiopathic and secondary chronic intestinal pseudo-obstruction:A retrospective single center study
Scientific Title:Acronym	Difference in clinical features between idiopathic and secondary chronic intestinal pseudo-obstruction
Region	Japan

Condition
Condition	Chronic Intestinal Pseudo-obstruction (CIPO)
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the clinical characteristics and prognosis between idiopathic and secondary CIPO
Basic objectives2	Others
Basic objectives -Others	To find the effective therapy in each type and help establish the treatment strategy in patients with CIPO
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of intravenous hyperalimentation (IVH) requirement
Key secondary outcomes	Ratio of idiopathic and secondary CIPO Underlying diseases in secondary CIPO Age of onset Cine-MRI findings Nutritional status (serum albumin level, body mass index) Effective rate of enteric sterilization Prognosis (Mortality rate)

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	Patients who meet following 1-7 criteria (idiopathic CIPO) or 1-6 criteria (secondary CIPO) are eligible Diagnostic criteria of CIPO 1. Persistent or recurrent symptoms of bowel obstruction such as abdominal bloating, nausea, vomiting, and pain 2. Disease duration of more than 2 months for newborn onset and 6 months for onset after infancy 3. Dilatation of gastrointestinal tract and air-fluid level on radiological images 4. No evidence of structural diseases 5. No morphological abnormalities in the plexus on HE staining of intestinal full-thickness biopsy 6. Exclusion of megacystis microcolon intestinal hypoperistalsis syndrome (MMIHS) and segmental dilatation of intestine for pediatric patients 7. Exclusion of secondary CIPO
Key exclusion criteria	1)Patients with current malignant diseases under treatment (patients with stable condition and not requiring active treatment are allowed) 2)Patients with severe psychiatric diseases (patients with stable condition are allowed)
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hidenori Middle name Last name Ohkubo
Organization	Yokohama City University Hospital
Division name	Division of Hepatology and Gastroenterology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2800
Email	ohkuboh@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Hidenori Middle name Last name Ohkubo
Organization	Yokohama City University Hospital
Division name	Division of Hepatology and Gastroenterology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2800
Homepage URL
Email	ohkuboh@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 08 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	Preinitiation
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A single center retrospective study.

Management information
Registered date	2020 Year 06 Month 05 Day
Last modified on	2020 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046420

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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