UMIN-CTR Clinical Trial

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
Email	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
Email	08medrfcab@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047871