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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005402
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Saiseikai Matsusaka Gereral Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006412

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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