UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005402 |
|---|---|
| Receipt number | R000006412 |
| Scientific Title | Examination of the method of selecting appropriate physical properties of nutrients by radiographic findings in patients with PEG. |
| Date of disclosure of the study information | 2011/04/07 |
| Last modified on | 2012/10/06 06:10:38 |
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Basic information
Public title
Examination of the method of selecting appropriate physical properties of nutrients by radiographic findings in patients with PEG.
Acronym
Examination of the method of selecting appropriate physical properties of nutrients by radiographic findings in patients with PEG.
Scientific Title
Examination of the method of selecting appropriate physical properties of nutrients by radiographic findings in patients with PEG.
Scientific Title:Acronym
Examination of the method of selecting appropriate physical properties of nutrients by radiographic findings in patients with PEG.
Region
| Japan |
Condition
Condition
Patients with PEG
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether X-ray examinations using the contrast medium with different physical properties are useful for the selection of appropriate physical properties of nutrients in patients with PEG. And also evaluate safety of the method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of gastroesophageal reflux of contrast medium.
Key secondary outcomes
Occurrence of adverse events.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
1.X-ray examination using the liquid contrast medium. 2.X-ray examination using the half-solid contrast medium.
Interventions/Control_2
1.X-ray examination using the half-solid contrast medium. 2.X-ray examination using the liquid contrast medium.
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 over 20 years-old and regardless of gender
2) Patients who have given written informed consent by himself or a his representative.
3) Patients scheduled for PEG
Key exclusion criteria
1) Patients with ileus.
2) Patients with no residual intestinal function.
3) Patients with PEG for decompression.
4) Patients with bronchial incision and bronchial cannula.
5)Patients with pneumonia
6) Patients with a history of upper digestive tract resection. Excluding a minor resection such as polypectomy.
7)Patients with allergy to apple elements.
8)Patients with a history of hypersensitivity to iodine or iodinated contrast media.
9)Patients who determine inappropriate to enroll clinical study by investigator.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuya shimizu |
Organization
Saiseikai Matsusaka General Hospital
Division name
Department of Internal Medicine
Zip code
Address
1-15-6 Asahi, Matsusaka city, Mie 515-8557, Japan
TEL
0598-51-2626
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuya Shimizu |
Organization
Saiseikai Matsusaka General Hospital
Division name
Department of Internal Medicine
Zip code
Address
1-15-6 Asahi, Matsusaka city, Mie 515-8557, Japan
TEL
0598-51-2626
Homepage URL
Sponsor or person
Institute
Saiseikai Matsusaka Gereral Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ishinomaki Senshu University
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
済生会松阪総合病院（三重県）、医療法人清田病院（北海道）、町立長沼病院（北海道）/ Saiseikai Matsusaka General Hospital, Kiyota Hospital, Naganuma municipal Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 07 | Day |
Last modified on
| 2012 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006412
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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