UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029973 |
|---|---|
| Receipt number | R000034235 |
| Scientific Title | Perioperative Antioxidant enha nced Nutrition Effect on Liver S urgery |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2017/11/15 07:51:54 |
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Basic information
Public title
Perioperative Antioxidant enha nced Nutrition Effect on Liver S urgery
Acronym
PANEL Study
Scientific Title
Perioperative Antioxidant enha nced Nutrition Effect on Liver S urgery
Scientific Title:Acronym
PANEL Study
Region
| Japan |
Condition
Condition
Liver resection patients
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of periop erative administration of enteral nutrition with anti-oxidants (AO D; ANOM(R)) for liver surgery p atients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence rate of infectious complications within 14 postoperative days
Key secondary outcomes
1) Changes in antioxidatic effect , 2) Improvement in liver function tests, 3) Changes in perioperative nutritional index, 4) Occurrence rate of infectious complications within 30 postoperative d ays, 5) Length of hospital stay, 6) Adverse effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Enteral nutrition with antioxidant supplementation (600 kcal/d ay, ANOM (R)) are given 5 days preoperatively
Interventions/Control_2
Normal enteral nutrition (600 k cal/day for 5 days preoperatively)
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
Patient undergoing liver resection including liver cirrhosis cases
Over 18 years old
Written informed consent is available
Key exclusion criteria
Without conditions as follows: Liver dysfunction like CHild-Pugh C or Liver damage C, Patients with hepatic coma, Patients with severe diabetes, ileus, gastroenteritis, short bowel syndrome, postgastrectomy status
Congenital abnormalities in ami no acids metabolism
Allergy in milk
Allergy in ANOM(R)
Pregnancy
Responsuble physician diagnose d patients as inapropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIROYUKI SAKURAI |
Organization
MIE UNIVERSITY
Division name
MEDICAL AND NURSING EDUCATION CENTER
Zip code
Address
2-174 Edobashi, Tsu, Mie, 514- 8507, JAPAN
TEL
059-231-5654
HIRODON@CLIN.MEDIC.MIE-U.AC.JP
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIROYUKI SAKURAI |
Organization
MIE UNIVERSITY
Division name
MEDICAL AND NURSING EDUCATION CENTER
Zip code
Address
2-174 Edobashi, Tsu, Mie, 514- 8507, JAPAN
TEL
059-231-5654
Homepage URL
HIRODON@CLIN.MEDIC.MIE-U.AC.JP
Sponsor or person
Institute
MIE UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
MIE UNIVERSITY
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 15 | Day |
Last modified on
| 2017 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034235
| Research Plan | |
|---|---|
| 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 |
