UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009119 |
|---|---|
| Receipt number | 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 12:31:52 |
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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
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
shimodamitsugi@hotmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010570
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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