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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040669
Receipt No. R000046420
Scientific Title Difference in clinical features between idiopathic and secondary chronic intestinal pseudo-obstruction:A retrospective single center study
Date of disclosure of the study information 2020/06/08
Last modified on 2020/06/05

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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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