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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027912
Receipt No. R000031973
Scientific Title Sirolimus for treatment of bronchial stenosis after lung transplantation
Date of disclosure of the study information 2017/08/01
Last modified on 2017/06/24

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Basic information
Public title Sirolimus for treatment of bronchial stenosis after lung transplantation
Acronym Sirolimus for post-lung transplant bronchial stenosis
Scientific Title Sirolimus for treatment of bronchial stenosis after lung transplantation
Scientific Title:Acronym Sirolimus for post-lung transplant bronchial stenosis
Region
Japan

Condition
Condition Bronchial stenosis after lung transplantation
Classification by specialty
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the efficacy and the safety siroliums for treatment of bronchial stenosis after lung transplantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevention of recurrent bronchial stenosis
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 NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Administration of sirolimus
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 Post-lung transplant patients with recurrent bronchial stenosis after lung transplantation who need conventional treatment every 3 months
Key exclusion criteria - Patients with past-history of bronchial anastomosis dehiscence
- Patients with interstitial pneumonia or malignancy or delayed bronchial anastomosis healing
- Post- single lung transplant patients for interstitial pneumonia
- Patients in pregnancy or lactation
- Patients who want to be pregnant

Target sample size 5

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hisashi Oishi
Organization Tohoku University Hospital
Division name Thoracic Surgery
Zip code
Address 1-1 Seiryomachi, Aobaku, Sendai 980-8575 Japan
TEL 022-717-8521
Email hisashi.oishi.c7@tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hisashi Oishi
Organization Tohoku University Hospital
Division name Thoracic Surgery
Zip code
Address 1-1 Seiryomachi, Aobaku, Sendai 980-8575 Japan
TEL 022-717-8521
Homepage URL
Email hisashi.oishi.c7@tohoku.ac.jp

Sponsor
Institute Department of Thoracic Surgery, Tohoku University Hospital
Institute
Department

Funding Source
Organization Department of Thoracic Surgery, Tohoku University Hospital
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
Address
Tel
Email

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 08 Month 01 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 07 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 18 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 06 Month 24 Day
Last modified on
2017 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031973

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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