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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009119
Receipt No. R000010570
Scientific Title NAFLD and NASH inhibition test after PD, using pancelipase load test
Date of disclosure of the study information 2012/10/15
Last modified on 2013/10/15

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Basic information
Public title NAFLD and NASH inhibition test after PD, using pancelipase load test
Acronym Fatty liver inhibition test after PD
Scientific Title NAFLD and NASH inhibition test after PD, using pancelipase load test
Scientific Title:Acronym Fatty liver inhibition test after PD
Region
Japan Asia(except Japan)

Condition
Condition fatty liver after PD
Classification by specialty
Gastrointestinal surgery Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is evaluated whether revelation control of fatty liver is accepted by prescribing pancre-lipase for the patient after PD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The rate of incidence of a fatty liver
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Medication of pancre-lipase
Interventions/Control_2 no treatment
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
65 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria After pancreatoduodenectomy
Key exclusion criteria 1) patient with HBs ana/or HCV positive
2)Patietns had fatt liver before PD
3) without fatty liver in histlogically
4) The infection patient who needs medical treatment
5)The patient of malabsorption syndrome
6)patients who had reoperation
7)patients who had rejected this srudy
8)patients had allergy of this drug
9)patients had pregnacy,
Target sample size 134

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name keiichi Kubota
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address 880 Kitakobayashi, Mubu, Tochigi, Japan
TEL 0282-87-2158
Email shimodamitsugi@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mitsugi Shimoda
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address 880 Kitakobayashi, Mubu, Tochigi, Japan
TEL 0282-87-2158
Homepage URL
Email shimodamitsugi@hotmail.com

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 獨協医科大学病院

Other administrative information
Date of disclosure of the study information
2012 Year 10 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 Open public recruiting
Date of protocol fixation
2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 03 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
2012 Year 10 Month 15 Day
Last modified on
2013 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010570

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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