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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017266
Receipt No. 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

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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
Email 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
Email nishikawa@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020030

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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