UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030454 |
|---|---|
| Receipt number | R000034770 |
| Scientific Title | Living/ deceased donor intestinal transplantation using standardized immunosuppression protocol |
| Date of disclosure of the study information | 2017/12/18 |
| Last modified on | 2017/12/18 18:44:33 |
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Basic information
Public title
Living/ deceased donor intestinal transplantation using standardized immunosuppression protocol
Acronym
Intestinal transplantation using standardized immunosuppression protocol
Scientific Title
Living/ deceased donor intestinal transplantation using standardized immunosuppression protocol
Scientific Title:Acronym
Intestinal transplantation using standardized immunosuppression protocol
Region
| Japan |
Condition
Condition
irreversible intestinal failure
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To define the efficacy of intestinal transplantation for patients with irreversible intestinal failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient and graft survival after intestinal transplantation
rejection rate after transplantation
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
| Medicine | Maneuver |
Interventions/Control_1
Transplantation group using standardized immunosuppression protocol
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
| Not applicable |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with irreversible intestinal failure complicated with bellow conditions.
1. Thrombosis/ Occlusion of central venous access
2. intestinal failure associated liver disease
3. Poor quality of life
Key exclusion criteria
Patients having allergy to immunosuppressive drug
Pregnant or breast feeding female patients
Patients having uncontrollable infection
Patients having uncontrollable malignancy
Patients having uncontrollable mental disorders
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Nio |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pediatric Surgery
Zip code
Address
1-1 Seiryo-machi, Aobaku, Sendai
TEL
022-717-7237
mnio@ped-surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoshi Wada |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pediatric Surgery
Zip code
Address
1-1 Seiryo-machi, Aobaku, Sendai
TEL
022-717-7237
Homepage URL
wada@ped-surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 12 | Month | 18 | 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
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | 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
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034770
| 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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| Registered date | File name |
