UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004777 |
|---|---|
| Receipt number | 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 22:19:42 |
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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
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
Sponsor or person
Institute
Surgical Oncology, Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005688
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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