UMIN-CTR Clinical Trial

Basic information
Public title	Additional Effect of Perioperative, Compared with Preoperative, Immunonutrition After Pancreaticoduodenectomy: A Randomized, Controlled Trial
Acronym	Additional Effect of Perioperative, Compared with Preoperative, Immunonutrition After Pancreaticoduodenectomy: A Randomized, Controlled Trial
Scientific Title	Additional Effect of Perioperative, Compared with Preoperative, Immunonutrition After Pancreaticoduodenectomy: A Randomized, Controlled Trial
Scientific Title:Acronym	Additional Effect of Perioperative, Compared with Preoperative, Immunonutrition After Pancreaticoduodenectomy: A Randomized, Controlled Trial
Region	Japan

Condition
Condition	Pancreatic head cancer, distal cholangiocarcinoma, ampullary carcinoma, IPMN
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of present study is to evaluate whether perioperative, compared with preoperative, immunonutrition has additional effects on cell-mediated immunity and the infection rate after pancreaticoduodenectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Postoperative Infectious Complication[ Time Frame: 30 days ]
Key secondary outcomes	Plasma IL-6, PGE2, CRP, Th1/Th2 Balance. [ Time Frame: 14 days ]

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	Intervention Dietary Supplement: Oral IMPACT oral supplementation for 5 days (1L/day) before surgery and prolonged after 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	Control Dietary Supplement: Oral IMPACT oral supplementation 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_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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients underwent pancreaticoduodenectomy
Key exclusion criteria	age younger than 18 years ongoing infection gastrointestinal obstruction respiratory dysfunction cardiac dysfunction hepatic dysfunction renal failure history of recent immunosuppressive or immunological diseases preoperative evidence of widespread metastatic disease
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Katsunori Middle name Last name Furukawa
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Surgery
Zip code	260-0856
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-0856, Japan.
TEL	043-226-2103
Email	k-furukawa@umin.ac.jp

Public contact
Name of contact person	1st name Katsunori Middle name Last name Furukawa
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Surgery
Zip code	260-2856
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-0856, Japan.
TEL	043-226-2103
Homepage URL	http://www.ho.chiba-u.ac.jp/5/
Email	k-furukawa@umin.ac.jp

Sponsor
Institute	Department of General Surgery, Chiba University Graduate School of Medicine
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)

IRB Contact (For public release)
Organization	Chiba University
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-0856, Japan.
Tel	043-226-2103
Email	k-furukawa@umin.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01969110
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉大学医学部附属病院（千葉）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/30540966
Number of participants that the trial has enrolled	71
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	Completed
Date of protocol fixation	2009 Year 02 Month 01 Day
Date of IRB	2013 Year 01 Month 30 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2014 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 17 Day
Last modified on	2020 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028140