UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024449 |
|---|---|
| Receipt number | 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 14:05:25 |
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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
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/
k-furukawa@umin.ac.jp
Sponsor or person
Institute
Department of General Surgery, Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028140
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
