UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040669
Receipt number 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 19:34:21

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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 or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



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

Value
https://center6.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