UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010760 |
|---|---|
| Receipt number | R000012581 |
| Scientific Title | Randomized contol trials of immunonutrition in perioperative management for hepato-pancreatico-biliary surgery |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2019/11/24 12:00:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
motoyama@shinshu-u.ac.jp
Sponsor or person
Institute
First department of surgery, Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012581
