UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014368 |
|---|---|
| Receipt number | R000016721 |
| Scientific Title | Clinical Study of Pancreatectomy with Autologous Islet Transplantation for Treatment of Chronic Pancreatitis |
| Date of disclosure of the study information | 2014/06/25 |
| Last modified on | 2014/06/24 20:00:30 |
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Basic information
Public title
Clinical Study of Pancreatectomy with Autologous Islet Transplantation for Treatment of Chronic Pancreatitis
Acronym
PAITTCP
Scientific Title
Clinical Study of Pancreatectomy with Autologous Islet Transplantation for Treatment of Chronic Pancreatitis
Scientific Title:Acronym
PAITTCP
Region
| Japan |
Condition
Condition
Chronic Pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the aim of this study is to assess the effects and safety of Total pancreatectomy with auto-islet transplantation for patients with chronic pancreatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the safety of Pancreatectomy and islet transplantation and to assess the 12-month endpoint post treatment in patients. The endpoint will consist of the reduction of the pain and sustained good glycemic control (HbA1c < 7.4%) without hypoglycemic events.
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
Pancreatectomy with Autologous Islet Transplantation
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic pancreatitis with severe pain which is resistant against any other treatment
Key exclusion criteria
Alcohol abuse
type 1 diabetes
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Shimoda |
Organization
Research Institute, National Center for Global Health and Medicine
Division name
Department of pancreatic islet cell transplantation project
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655 Japan
TEL
03-3202-7181
mshimoda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Shimoda |
Organization
Research Institute, National Center for Global Health and Medicine
Division name
Department of pancreatic islet cell transplantation project
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655 Japan
TEL
03-3202-7181
Homepage URL
mshimoda@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
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
| 2014 | Year | 06 | Month | 25 | 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 | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
| 2014 | Year | 06 | Month | 24 | Day |
Last modified on
| 2014 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016721
