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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004108
Receipt No. 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

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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
Email 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
Email t1006koichi@yahoo.co.jp

Sponsor
Institute Yokohama city univercity
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004942

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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