UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007533 |
|---|---|
| Receipt number | R000008885 |
| Scientific Title | Explorative trial of suppression effect of preoperative enteral nutrition enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy :a double blinded and randomaized controlled trial |
| Date of disclosure of the study information | 2012/03/30 |
| Last modified on | 2012/03/19 15:25:29 |
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Basic information
Public title
Explorative trial of suppression effect of preoperative enteral nutrition
enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy
:a double blinded and randomaized controlled trial
Acronym
Explorative trial of suppression effect of preoperative enteral nutrition
enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy
:a double blinded and randomaized controlled trial
Scientific Title
Explorative trial of suppression effect of preoperative enteral nutrition
enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy
:a double blinded and randomaized controlled trial
Scientific Title:Acronym
Explorative trial of suppression effect of preoperative enteral nutrition
enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy
:a double blinded and randomaized controlled trial
Region
| Japan |
Condition
Condition
Patients to require pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify suppression effect of preoperative enteral nutrition
enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The serum IL-6 value before and after pancreaticoduodenectomy
Key secondary outcomes
The nutrition status after preoperative enteral nutrition enrichied with Eicosapentaenoic Acid(EPA)
The cytokine level after pancreaticoduodenectomy
CD4/CD8 T lymphocyte balance after pancreaticoduodenectomy
The incidence of post-operative infectious complications
The incidence of adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
enteral nutrition
enrichied with Eicosapentaenoic Acid(EPA)
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)Histologically or clinically diagnosed as pancreaticoduodenal cancer (i.e. pancreas head cancer, biliary cancer, papilla cancer or duodenal cancer)
(2)Treated with curative resection
(3)Needed to be admitted for a week or more in order to relieve jaundice
(4)ECOG performance formans status is 0 or 1
(5)Fulfil all following conditions
WBC < 10,000/mm3
Hb > 8.0g/dL
Cre < 1.5mg/dl
Key exclusion criteria
(1)With poor oral intake
(2)With other nutrition therapy
(3)Being immunocompromised status or receiving steroids
(4)With uncontrolled diabetes mellitus
(5)With inflammatory bowel disease
(6)With bacterial or viral infection
(7)With radiation therapy, chemotherapy or nutrition therapy before registration
(8)With psychiatric disorder
(9)Possibly pregnant
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Uesaka |
Organization
Shizuoka Cancer Center
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address
1007 Shimonagakubo Nagaizumityou Suntougun Shizuoka Japan
TEL
0559895222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Aoki |
Organization
Shizuoka Cancer Center
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address
1007 Shimonagakubo Nagaizumityou Suntougun Shizuoka Japan
TEL
0559895222
Homepage URL
shuichi1124@msn.com
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Pharma Valley Center
Organization
Division
Category of Funding Organization
Non profit foundation
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
静岡がんセンター(静岡県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 30 | 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
| 2012 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
| 2012 | Year | 03 | Month | 19 | Day |
Last modified on
| 2012 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008885
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
