UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective trial of transbronchial cryobiopsy to evaluate its safety and utility
Acronym	Multicenter prospective trial of transbronchial cryobiopsy
Scientific Title	Multicenter prospective trial of transbronchial cryobiopsy to evaluate its safety and utility
Scientific Title:Acronym	Multicenter prospective trial of transbronchial cryobiopsy
Region	Japan

Condition
Condition	Diffuse interstitial lung disease (interstitial pneumonia, idiopathic pulmonary fibrosis, chronic hypersensitivity pneumonitis, sarcoidosis), malignant tumor (lung cancer, mesothelioma, metastatic lung carcinoma), respiratory infectious disease (tuberculosis, nontuberculosis mycobacterial infection, pulmonary aspergillosis), other diseases
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and utility of transbronchial cryobiopsy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Provability of moderate to severe adverse events
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	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Respiraotry disease
Key exclusion criteria	1) Patients are excluded if they have past history of severe allergy to sedative drugs (lidocaine, midazolam, pethidine and so on) 2) Patients are excluded if they are suspected to have tendency of bleeding from cryobiopsy lesion because of aneurysm of bronchoartery and lung metastasis of renal cell carcinoma and so on. 3) Patients are excluded if they can't stop anticoagulation therapy. 4) Patients are excluded if they have uncontrolled comlication such as unstable angina, acute myocardial infarction, heart failure and severe bronchial asthma attack. 5) Patients are excluded if they are pregnant. 6) Patients are excluded if their doctor decide not to include.
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Middle name Last name Minoru Inomata
Organization	Japanese Red Cross Medical Center
Division name	Department of Pulmonary Medicine
Zip code
Address	4-1-22 Hiroo Shibuya-ku Tokyo
TEL	03-3400-1311
Email	inomataminoru@nms.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Minoru Inomata
Organization	Japanese Red Cross Medical Center
Division name	Department of Pulmonary Medicine
Zip code
Address	4-1-22 Hiroo Shibuya-ku Tokyo
TEL	03-3400-1311
Homepage URL
Email	inomataminoru@nms.ac.jp

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	Japanese Red Cross Medical Center
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
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	2018 Year 07 Month 04 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	Completed
Date of protocol fixation	2018 Year 07 Month 04 Day
Date of IRB	2018 Year 07 Month 04 Day
Anticipated trial start date	2018 Year 07 Month 04 Day
Last follow-up date	2019 Year 08 Month 16 Day
Date of closure to data entry	2019 Year 12 Month 01 Day
Date trial data considered complete	2019 Year 12 Month 27 Day
Date analysis concluded	2019 Year 12 Month 27 Day

Other
Other related information	To evaluate safety and utility of transbronchial cryobiopsy

Management information
Registered date	2018 Year 07 Month 04 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037791