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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Chronic Intestinal Pseudo-obstruction (CIPO) | ||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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) |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
ohkuboh@yokohama-cu.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |