UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003118 |
|---|---|
| Receipt number | R000003783 |
| Scientific Title | Clinical study of efficacy of postoperative enteral nutrition using "MEIN(R)" for patients of esophageal cancer |
| Date of disclosure of the study information | 2010/02/03 |
| Last modified on | 2012/02/26 13:44:50 |
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Basic information
Public title
Clinical study of efficacy of postoperative enteral nutrition using "MEIN(R)" for patients of esophageal cancer
Acronym
Clinical study of efficacy of postoperative enteral nutrition using "MEIN(R)" for patients of esophageal cancer
Scientific Title
Clinical study of efficacy of postoperative enteral nutrition using "MEIN(R)" for patients of esophageal cancer
Scientific Title:Acronym
Clinical study of efficacy of postoperative enteral nutrition using "MEIN(R)" for patients of esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate efficacy and safeness of enteral nutrition using "MEIN(R)" for preoperative and postoperative patients of esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
CRP
Key secondary outcomes
inflammatory marker(IL-6,TNF-alpha),SIRS score,postoperative complication,lean body mass
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
MEIN(R)
Interventions/Control_2
MEIBALANCE(R)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients of esophageal cancer who undergo surgery
Key exclusion criteria
patients who cannot receive enteral nutrition therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michitaka Suzuki |
Organization
Showa university Yokohama northern hospital
Division name
Digestive disease center
Zip code
Address
35-1,Chigasaki-chuo,Tsuduki-ku,Yokohama,Kanagawa,Japan
TEL
045-949-7000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michitaka Suzuki |
Organization
Showa university Yokohama northern hospital
Division name
Digestive disease center
Zip code
Address
35-1,Chigasaki-chuo,Tsuduki-ku,Yokohama,Kanagawa,Japan
TEL
045-949-7000
Homepage URL
suzuki-tmd@umin.ac.jp
Sponsor or person
Institute
Digestive disease center,Showa university Yokohama northern hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive disease center,Showa university Yokohama northern hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Meiji Nyugyo
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
昭和大学横浜市北部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | 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
| 2010 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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
| 2010 | Year | 01 | Month | 31 | Day |
Last modified on
| 2012 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003783
