UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001480 |
|---|---|
| Receipt number | R000001794 |
| Scientific Title | Examination of the usefulness of supplementary enteral nutrition management using an elemental diet after gastric cancer surgery |
| Date of disclosure of the study information | 2008/11/04 |
| Last modified on | 2010/01/29 19:57:36 |
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Basic information
Public title
Examination of the usefulness of supplementary enteral nutrition management using an elemental diet after gastric cancer surgery
Acronym
Examination of the usefulness of elemental diet after gastric cancer surgery
Scientific Title
Examination of the usefulness of supplementary enteral nutrition management using an elemental diet after gastric cancer surgery
Scientific Title:Acronym
Examination of the usefulness of elemental diet after gastric cancer surgery
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of long-term enteral nutrition on improving the nutritional status and QOL.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Tolerance of oral intake of an elemental diet
Key secondary outcomes
Physical measurement, biochemical tests
Food intake
QOL evaluation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Elental: over 300Kcal/day
In total of one year administration of Elental
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had undergone gastrectomy mainly for gastric cancer
Patients assessed by the attending physician to be suitable for inclusion
Key exclusion criteria
Patients with severe diabetes, and patients suspected to have abnormal sugar metabolism because of being given high doses of steroids
Patients in the first 3 months of pregnancy, and patients planning to become pregnant and receiving 5000 IU/day or more of vitamin A
Patients with abnormal amino acid metabolism
Patients with mental disorders
Patients assessed by the attending physician to be unsuitable for inclusion
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Inoue |
Organization
Kawasaki Hospital
Division name
Head, Department of Surgery Administration
Zip code
Address
3-3-1 Higashiyama-cho, Hyogo-ku, Kobe, Hyogo 652-0042 Japan
TEL
078-511-3131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kamigaki |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastrointestinal Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017 Japan
TEL
078-382-5111
Homepage URL
http://www.med.kobe-u.ac.jp/surg1/index.html
Sponsor or person
Institute
Division of Gastrointestinal Surgery, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | 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
| 2008 | Year | 11 | Month | 03 | Day |
Last modified on
| 2010 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001794
