UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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"
Title of the study (Brief title)	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	shuji Isaji
Organization	Mie universuty
Division name	Department of Hepatobiliary Pancreas and Transplant Surgery
Address	2-174 Edobashi, Tsu, Mie
TEL	059-232-1111
Email	shujiisaji1@mac.com

Public contact
Name of contact person	Masashi Kishiwada
Organization	Mie universuty
Division name	Department of Hepatobiliary Pancreas and Transplant Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 03 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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