UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007533
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email shuichi1124@msn.com

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008885

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.