UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041949 |
|---|---|
| Receipt number | R000047871 |
| Scientific Title | Exploratory study of therapeutic strategies for invasive pulmonary aspergillosis after liver transplantation |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2020/09/30 13:48:44 |
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Basic information
Public title
Risk Factors of Invasive Pulmonary Aspergillosis after Living and Deceased Donor Liver Transplantation and Lessons from Successfully Treated Cases
Acronym
Exploratory study of therapeutic strategies for invasive pulmonary aspergillosis after liver transplantation
Scientific Title
Exploratory study of therapeutic strategies for invasive pulmonary aspergillosis after liver transplantation
Scientific Title:Acronym
Treatment strategies for invasive pulmonary aspergillosis after liver transplantation
Region
| Japan |
Condition
Condition
Liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pulmonary Aspergillus infection after liver transplantation was highly invasive and remains a fatal disease. Although only antifungal drugs are recommended for the treatment of invasive pulmonary aspergillosis, we experienced a case in which early pulmonary resection was useful as a life-saving strategy for invasive pulmonary aspergillosis after liver transplantation. Therefore, the purpose of this study was to suggest that adding early lung resection to the treatment strategy for invasive pulmonary aspergillosis after liver transplantation may improve outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Life-saving rates of invasive pulmonary aspergillosis after liver transplantation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 2 | months-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone living- or deceased-donor liver transplants in our hospital
Key exclusion criteria
Patients who could not undergo a liver transplant
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Shinoda |
Organization
Keio University School of Medicine
Division name
Department of surgery
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3802
masa02114@keio.jp
Public contact
Name of contact person
| 1st name | Kodai |
| Middle name | Kitago |
| Last name | Abe |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3802
Homepage URL
08medrfcab@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
Keio University School of Medicine, Ethics Committee
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
Tel
0353633802
08medrfcab@keio.jp
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
| 2020 | Year | 09 | Month | 30 | 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
326
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective case-controlled study
Management information
Registered date
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047871
