UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Preoperative Immunonutrition in Patients Undergoing major hepatobiliary resection
Title of the study (Brief title)	Effects of Preoperative Immunonutrition in Patients Undergoing major hepatobiliary resection
Region	Japan

Condition
Condition	Bile Duct Cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatobiliary resection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	postoperative infectious complication
Key secondary outcomes	plasma IL-6, CRP, Th1/Th2 balance, resolvin E1

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Dietary Supplement: Oral IMPACT oral supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA Other Name: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Interventions/Control_2	ordinary diet
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	hemihepatectomy with bile duct resection
Key exclusion criteria	ongoing infection gastrointestinal obstruction respiratory dysfunction cardiac dysfunction hepatic dysfunction renal failure history of recent immunosuppressive or immunological disease preoperative evidence of widespread metastatic disease
Target sample size	40

Research contact person
Name of lead principal investigator	Katsunori Furukawa
Organization	Chiba University
Division name	Department of General Surgery
Address	1-8-1 inohana, chuo-ku, chiba city
TEL	043-222-7171
Email	k-furukawa@umin.ac.jp

Public contact
Name of contact person	Katsunori Furukawa
Organization	Chiba University
Division name	Department of General Surgery
Address	1-8-1 inohana, chuo-ku, chiba city
TEL	043-222-7171
Homepage URL
Email	k-furukawa@umin.ac.jp

Sponsor
Institute	Chiba University Department of General Surgery
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01256047
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 02 Month 01 Day
Anticipated trial start date	2009 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/26965712
Results
Other related information

Management information
Registered date	2016 Year 10 Month 24 Day
Last modified on	2016 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028250