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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005595
Receipt No. 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

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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
Email 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
Email tyoko@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006613

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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