UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017574 |
|---|---|
| Receipt number | R000020364 |
| Scientific Title | Efficacy of the Percutaneus Endoscopic Gastrojejunostomy (PEG-J) tube decompression therapy for patients with chronic intestinal pseudo-obstruction (CIPO) |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2018/10/02 19:38:12 |
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Basic information
Public title
Efficacy of the Percutaneus Endoscopic Gastrojejunostomy (PEG-J) tube decompression therapy for patients with chronic intestinal pseudo-obstruction (CIPO)
Acronym
Efficacy of the PEG-J tube decompression therapy for the CIPO patients
Scientific Title
Efficacy of the Percutaneus Endoscopic Gastrojejunostomy (PEG-J) tube decompression therapy for patients with chronic intestinal pseudo-obstruction (CIPO)
Scientific Title:Acronym
Efficacy of the PEG-J tube decompression therapy for the CIPO patients
Region
| Japan |
Condition
Condition
Chronic intestinal pseudo-obstruction(CIPO)
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the decompression effect of the PEG-J tube in patients with CIPO, and establish the novel treatment available at home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Diameter of the small intestine before and after PEG-J.
2) Frequency of abdominal pain, bloating, and nausea
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Percutaneus endoscopic gastrojejunostomy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who meet the diagnostic criteria for CIPO proposed by Ministry of Health, Labor, and Welfare.
2) Patients of whom 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) Patients with psychiatric disorders.
5) Patients judged inappropriate for the trial by investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
nakajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Ohkubo |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
ohkuboh@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research of Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020364
