UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009455 |
|---|---|
| Receipt number | R000011110 |
| Scientific Title | Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium. |
| Date of disclosure of the study information | 2012/12/03 |
| Last modified on | 2013/12/09 21:28:45 |
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Basic information
Public title
Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.
Acronym
Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.
Scientific Title
Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.
Scientific Title:Acronym
Evaluate incidence of gastroesophageal reflux with high viscosity contrast medium.
Region
| Japan |
Condition
Condition
Patients with PEG
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the incidence of gastroesophageal reflux with high (10,000mPa/s) and medium (6,000mPa/s , historical data) viscosity contrast medium.
Also evaluate the factors associated with gastroesophageal reflux.
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 .
Key secondary outcomes
Incidence of gastroesophageal reflux by hiatus hernia.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
X ray examination with high viscosity contrast medium injected through gastrostoma.
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 older than 20 years.
2)Patients who have given written informed consent by himself or his representative.
3)Patients with PEG
Key exclusion criteria
1)Patients with ileus.
2)Patients with no residual intestinal function.
3)Patients with gastrostoma 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 minor resection such as polypectomy.)
7)Patients with allergy to apple.
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
70
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
nst@matsusaka.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Matsusaka General 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
| 2012 | Year | 12 | Month | 03 | 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
| 2012 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 02 | Day |
Last modified on
| 2013 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011110
