UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007119 |
|---|---|
| Receipt number | R000008091 |
| Scientific Title | Clinical apprication of auto-islet transplantation for the patients recieved total pancreatectomy with non-malignant pancreatic tumor |
| Date of disclosure of the study information | 2012/01/24 |
| Last modified on | 2012/01/23 16:37:55 |
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Basic information
Public title
Clinical apprication of auto-islet transplantation for the patients recieved total pancreatectomy with non-malignant pancreatic tumor
Acronym
Auto-islet transplantation for the patients recieved total pancreatectomy with non-malignant pancreatic tumor
Scientific Title
Clinical apprication of auto-islet transplantation for the patients recieved total pancreatectomy with non-malignant pancreatic tumor
Scientific Title:Acronym
Auto-islet transplantation for the patients recieved total pancreatectomy with non-malignant pancreatic tumor
Region
| Japan |
Condition
Condition
benign pancreatic tumor, chronic pancreatitis, traumatic injury of the pancreas
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clearfy the safety and effciency for the auto-transplantaion of the patients who recieve total pancreatectomy with non-malignant pancreatic desease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Overall survivals, Graft(transplanted islets) survaivals, insulin requirements
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Islet isolation
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
| 18 | years-old | < |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
same as above
Key exclusion criteria
same as above
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
Tokushima Univ.
Division name
Dep. digestive and transplant surgery
Zip code
Address
Kuramato cho 2-50-1,Tokushima city
TEL
088-633-9277
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima univ
Division name
Dep. digestive and transplant surgery
Zip code
Address
TEL
Homepage URL
tikemoto@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima univ
Institute
Department
Personal name
Funding Source
Organization
Tokushima univ
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 01 | Month | 23 | Day |
Last modified on
| 2012 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008091
