UMIN-CTR Clinical Trial

Basic information
Public title	Randomized contol trials of immunonutrition in perioperative management for hepato-pancreatico-biliary surgery
Acronym	IM-RCT
Scientific Title	Randomized contol trials of immunonutrition in perioperative management for hepato-pancreatico-biliary surgery
Scientific Title:Acronym	IM-RCT
Region	Japan

Condition
Condition	hepato-pancreatico-biliary malignancy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We verify the usefulness of immunonutrition therapy in perioperative management for hepato-pancreatico-biliary malignacies performing parallel comparison between two randomized groups of immunonutrition group and conventional one.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence of infectious complication
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Perioperative conventional nutritional therapy
Interventions/Control_2	Peioperative immunonutrition
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 hepato-pancreatico-biliary elective surgery with digestive tract dissection 2. Patient age is 20-80 years old 3. American Society of Anesthesiologists score 1-3 4. Provision of written informed consent
Key exclusion criteria	1. Bodyweight (BW) loss of 10 per cent or more within 6months before entry. 2. Performance status 2 or more on the Eastern Cooperative Oncology Group scale 3. Hepatic dysfunction (Child-Pugh score B or more) 4. Renal function (serum creatinine level > 1.8mg/dl) 5. Insulin-dependent diabetes mellitus 6. Concurrent active infection 7. The patients who determined to be inappropriate clinically as a sublect for this study
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichi Miyagawa
Organization	Shinshu University
Division name	First department of surgery
Zip code
Address	Asahi 3-1-1, Matsumoto, Nagano
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Hiroaki Motoyama
Organization	Shinshu University
Division name	First department of surgery
Zip code
Address
TEL
Homepage URL
Email	motoyama@shinshu-u.ac.jp

Sponsor
Institute	First department of surgery, Shinshu University
Institute
Department

Funding Source
Organization	First department of surgery, Shinshu University
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 10 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	Terminated
Date of protocol fixation	2012 Year 09 Month 01 Day
Date of IRB	2012 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2017 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 05 Month 20 Day
Last modified on	2019 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012581