UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005595 |
|---|---|
| Receipt number | R000006613 |
| Scientific Title | Preventive effect of high doze digestive enzyme management on development of fatty liver after pancreaticoduodenactomy: a randomized controlled study |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2014/05/13 07:32:35 |
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Basic information
Public title
Preventive effect of high doze digestive enzyme management on development of fatty liver after pancreaticoduodenactomy: a randomized controlled study
Acronym
Preventive effect of high doze digestive enzyme management on development of fatty liver after pancreaticoduodenactomy: a randomized controlled study
Scientific Title
Preventive effect of high doze digestive enzyme management on development of fatty liver after pancreaticoduodenactomy: a randomized controlled study
Scientific Title:Acronym
Preventive effect of high doze digestive enzyme management on development of fatty liver after pancreaticoduodenactomy: a randomized controlled study
Region
| Japan |
Condition
Condition
Planned to undergo pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the preventive effect of high doze digestive enzyme management on development of fatty liver after pancreaticoduodenactomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Rate of fatty liver development
Key secondary outcomes
Analysis of contributing factor in development of fatty liver
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group: Oral administration of digestive enzymes (common doze) for at least 12 months after pancreaticoduodenectomy
Interventions/Control_2
Test group: Oral administration of digestive enzymes (high doze) for at least 12 months after pancreaticoduodenectomy
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
Planned to undergo pancreaticoduodenectomy
R0 operation
ASA score 1-3
Adequate organ function
Written informed consent
Key exclusion criteria
Active infection
Emergency operation
Fatty liver (pre-operation)
Uncontrolled diabetes mellitus
Alcohol intake (post-operation)
Positive HBs antigen or HCV antibody
ASA score 4 and more
Other reason that attending doctors consider
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinich Miyagawa |
Organization
Shinshu University School of Medicine
Division name
Department of Surgery
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2654
shinichi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahide Yokoyama |
Organization
Shinshu University School of Medicine
Division name
Department of Surgery
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2654
Homepage URL
tyoko@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 05 | Month | 12 | Day |
Last modified on
| 2014 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006613
| 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 |
