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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024449
Receipt No. R000028140
Scientific Title Additional Effect of Perioperative, Compared with Preoperative, Immunonutrition After Pancreaticoduodenectomy: A Randomized, Controlled Trial
Date of disclosure of the study information 2016/10/18
Last modified on 2020/03/20

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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

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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