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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004777
Receipt No. R000005688
Scientific Title Study of the effect of nutrition management on gastrointestinal mucosa and absorption after esophagectomy in esophageal cancer patient
Date of disclosure of the study information 2011/04/01
Last modified on 2014/12/24

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Basic information
Public title Study of the effect of nutrition management on gastrointestinal mucosa and absorption after esophagectomy in esophageal cancer patient
Acronym Study of the effect of nutrition management after esophagectomy
Scientific Title Study of the effect of nutrition management on gastrointestinal mucosa and absorption after esophagectomy in esophageal cancer patient
Scientific Title:Acronym Study of the effect of nutrition management after esophagectomy
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of total parenteral nutrition and enteral nutrition on gastrointestinal mucosa and absorption
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Change ratio of diamin oxidase (DAO) activity on the day before operation and 3rd and 7th day after operation
Key secondary outcomes Change of serum albumin, total protein and trace element concentration on the day before operation and 3rd and 7th day after operation

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
Medicine
Interventions/Control_1 Total parental nutrition
Interventions/Control_2 enteral nutrition
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) histlogically confirmed esophageal cancer
2) planning to undergo transthoracic esophagectomy and stomach reconstruction
3) WBC: 3000 /mm3>=, =<12000/mm3
and NE: >=1500 mm3
and PLT: >=100000 /mm3
and Hb: >=9.5 g/dL
and GOT, GPT: < 1.5 times of institutional upper limit
and T-Bil: =<1.5 g/dL
and ALP: < 2.5 times of institutional upper limit
and Cr: =<1.5 mg/dL
and Alb: >=2.8g/dL
4) Written informed concent
Key exclusion criteria 1) history of receiving gastrectomy
2) taking trace element
3) liver disease, mental disease, convulsive seizure, seizure disorder, heart disease, hemoglobinopathy, hemophilia, uncontrolled diabetes mellitus, autoimmune disease
4) history of severe adverse event due to ELNEOPA(R) or RACOL(R)
5) contraindication to ELNEOPA(R) or RACOL(R)
6) pregnancy
7) judged inadequate to this study by chief doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morihito Okada
Organization Hiroshima University Hospital
Division name Surgical Oncology
Zip code
Address 1-2-3 kasumi, Minami-ku, Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University Hospital
Division name Surgical Oncology
Zip code
Address 1-2-3 kasumi, Minami-ku, Hiroshima
TEL
Homepage URL
Email

Sponsor
Institute Surgical Oncology, Hiroshima University Hospital
Institute
Department

Funding Source
Organization Surgical Oncology, Hiroshima University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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 12 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2014 Year 11 Month 30 Day
Date of closure to data entry
2014 Year 11 Month 30 Day
Date trial data considered complete
2014 Year 12 Month 24 Day
Date analysis concluded
2014 Year 12 Month 24 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 22 Day
Last modified on
2014 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005688

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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