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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003118
Receipt No. 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

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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
Email

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
Email suzuki-tmd@umin.ac.jp

Sponsor
Institute Digestive disease center,Showa university Yokohama northern hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003783

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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