UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004108 |
|---|---|
| Receipt number | R000004942 |
| Scientific Title | A randomized controlled study of long term nutritional management by elemental diet after pancreaticoduodenectomy for biliary tract and pancreatic cancer. |
| Date of disclosure of the study information | 2010/08/31 |
| Last modified on | 2015/07/21 12:47:40 |
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Basic information
Public title
A randomized controlled study of long term nutritional management by elemental diet after pancreaticoduodenectomy for biliary tract and pancreatic cancer.
Acronym
Effect of long term nutritional management by elemental diet after pancreaticoduodenectomy.
Scientific Title
A randomized controlled study of long term nutritional management by elemental diet after pancreaticoduodenectomy for biliary tract and pancreatic cancer.
Scientific Title:Acronym
Effect of long term nutritional management by elemental diet after pancreaticoduodenectomy.
Region
| Japan |
Condition
Condition
Biliary tract cancer, Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of long term nutritional management by elemental diet for the improvement of nutritional status, morbidity and compliance of chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Neutral fat, Total cholesterol, ALT, AST, GGTP, Total protein, albumin, pre-albumin, lymphoid count, serum amino acid(Histidine), SF-36, period to return work, oral intake of baseline, 1, 3 and 6 month after operation
CA19-9 level, toxicity of chemotherapy
Key secondary outcomes
Body weight
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients administered elemental diet (ELENTAL) from enteral feeding tube for 3 month postoperatively.
Interventions/Control_2
Patients administered elemental diet (ELENTAL) from enteral feeding tube until beginning of oral intake.
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 received pancreaticoduodenectomy for bile duct cancer or pancreatic cancer
Key exclusion criteria
Patients who have distant metastasis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Taniguchi |
Organization
Yokohama city univercity
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045-787-2650
t1006koichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Taniguchi |
Organization
Yokohama city univercity
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045-787-2650
Homepage URL
t1006koichi@yahoo.co.jp
Sponsor or person
Institute
Yokohama city univercity
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | 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 | 08 | Month | 26 | Day |
Last modified on
| 2015 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004942
