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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029908
Receipt No. R000034164
Scientific Title Clinical studies of "the examination of the clinical benefit of the component nutrition agent which gives it to undernutrition and fatty liver caused after pancreatoduodenectomy"
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/10

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Basic information
Public title Clinical studies of "the examination of the clinical benefit of the component nutrition agent which gives it to undernutrition and fatty liver caused after pancreatoduodenectomy"
Acronym Clinical benefit of the component nutrition agent for undernutrition and the fatty liver after the pancreatoduodenectomy
Scientific Title Clinical studies of "the examination of the clinical benefit of the component nutrition agent which gives it to undernutrition and fatty liver caused after pancreatoduodenectomy"
Scientific Title:Acronym Clinical benefit of the component nutrition agent for undernutrition and the fatty liver after the pancreatoduodenectomy
Region
Japan

Condition
Condition pancreatoduodenectomy case
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By the oral postoperative additive enteral nutrient the improvement of the undernutrition state and the decrease of the incidence of the fatty liver, the improvement of the accomplishment rate of the adjuvant chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the improvement of the undernutrition state : Alb,BTR,pre-alb
Key secondary outcomes the decrease of the incidence of the fatty liver, the improvement of the accomplishment rate of the adjuvant chemotherapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Pancreatoduodenectomy case
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)The patients who underwent pancreatoduodenectomy
2)The age at registration is less than 80 years old 20 years old or older
3)PS is 0-2
4)Enough oral intake
5)male and female
6)Written informed consent form is obtained from the patients
Key exclusion criteria 1)The patients with the disease with diabetes, chronic renal failure, heart failure limiting quantity of calorie, quantity of protein or a fluid volume
2)The pregnant patients
3)The patients who is judged to be in condition to lack in ability for agreement
4)The patients with the severe psychic disturbance
5)The patients who judged that it was inadequate so that a physician conducted this study safely
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shuji Isaji
Organization Mie universuty
Division name Department of Hepatobiliary Pancreas and Transplant Surgery
Zip code
Address 2-174 Edobashi, Tsu, Mie
TEL 059-232-1111
Email shujiisaji1@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Kishiwada
Organization Mie universuty
Division name Department of Hepatobiliary Pancreas and Transplant Surgery
Zip code
Address 2-174 Edobashi, Tsu, Mie
TEL 059-232-1111
Homepage URL
Email kishiwad@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie universuty
Department of Hepatobiliary Pancreas and Transplant Surgery
Institute
Department

Funding Source
Organization Mie universuty
Department of Hepatobiliary Pancreas and Transplant Surgery
Organization
Division
Category of Funding Organization Other
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 2364
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 三重大学病院(三重県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 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 Enrolling by invitation
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
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 10 Day
Last modified on
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034164

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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