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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003722
Receipt No. R000004502
Scientific Title The efficacy of DPP-4 inhibitor after pancreatectomy
Date of disclosure of the study information 2010/07/01
Last modified on 2010/06/07

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Basic information
Public title The efficacy of DPP-4 inhibitor after pancreatectomy
Acronym The efficacy of DPP-4 inhibitor after pancreatectomy
Scientific Title The efficacy of DPP-4 inhibitor after pancreatectomy
Scientific Title:Acronym The efficacy of DPP-4 inhibitor after pancreatectomy
Region
Japan

Condition
Condition bebign diseases of pancreas
1)Serous cyst adenoma
2) Mucinous cyst adenoma
3) Lymphoepithelial cyst
4)Intraductal papillary mucinous neoplasm
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 DPP-4 inhibitor is newly medicine for type2 diabetes. Incretin has the function of increasing pancreatic beta cells and insulin secretion.The aim of this study is comparison of pancreatic beta cell function and GLP-1 after DPP-4 inhibitor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of pancreatic beta cell function and GLP-1 after DPP-4 inhibitor.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 DPP-4 inhibitor
Interventions/Control_2
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 1) The patients who have indications of operation.
2) The patients who have no inslin therapy or hypoglycemic agents.
3) Over 20-years-old patients.
Key exclusion criteria 1)The patients who have duodenal obstruction.
2)The patients who have anastomosis insufficiency and intraabdominal abscess after operation.
3)The patients who have no agreement.
4)Advanced cancer patients.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Tanaka
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Oncology
Zip code
Address 3-1-1 Maidashi, Fukuoka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Oncology
Zip code
Address
TEL
Homepage URL
Email y-mori@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences, Kyushu University
Department of Surgery and Oncology
Institute
Department

Funding Source
Organization BANYU
Organization
Division
Category of Funding Organization Profit organization
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
2010 Year 07 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 Preinitiation
Date of protocol fixation
2010 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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
2010 Year 06 Month 07 Day
Last modified on
2010 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004502

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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