UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017266 |
|---|---|
| Receipt number | R000020030 |
| Scientific Title | A phase II randomized controlled trial on effect of digestive enzymes for the development of nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy. |
| Date of disclosure of the study information | 2015/04/24 |
| Last modified on | 2015/05/27 09:48:18 |
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Basic information
Public title
A phase II randomized controlled trial on effect of digestive enzymes for the development of nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy.
Acronym
A phase II randomized controlled trial on effect of digestive enzymes for the development of nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy.
Scientific Title
A phase II randomized controlled trial on effect of digestive enzymes for the development of nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy.
Scientific Title:Acronym
A phase II randomized controlled trial on effect of digestive enzymes for the development of nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy.
Region
| Japan |
Condition
Condition
Patients who need pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the preventive effect of high potent digestive enzyme supplementation for the development of fatty liver after pancreaticoduodenectomy compared with conventional enzyme.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of non alcoholic fatty liver disease one year after surgery
Key secondary outcomes
The nutritional status, pancreatic endocrine and exocrine function one year after surgery
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
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 conventional digestive enzyme (common dosage) after pancreraticoduodenectomy
Interventions/Control_2
Test group: Oral administration of high potent digestive enzyme (common dosage) 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Planned to undergo pancreaticoduodenectomy
R0 or R1 operation
Sufficient oral intake at one month after surgery
Adequate organ function
Written informed consent
Key exclusion criteria
Preoperative fatty liver
Positive HBs antigen or HCV antibody
alcohol abuse
total pancreatectomy
R2 operation
Gastrointestinal disease with malabsorption
Other reason that attending doctors consider
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Yamamoto |
Organization
National Defense Medical College
Division name
Department of Surgery
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
042-995-1211
jyamamot@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Nishikawa |
Organization
National Defense Medical College
Division name
Department of Surgery
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
042-995-1211
Homepage URL
nishikawa@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
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
防衛医科大学校病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 24 | 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
| 2015 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 27 | 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
| 2015 | Year | 04 | Month | 24 | Day |
Last modified on
| 2015 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020030
| 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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