UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study of factors in diagnosis by means of bronchoscopy
Title of the study (Brief title)	Retrospective study of factors in diagnosis by means of bronchoscopy
Region	Japan

Condition
Condition	respiratory disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The safety and diagnostic yield of transbronchial cryobiopsy in respiratory disease
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	complications
Key secondary outcomes	procedure time, diagnostic yield

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	The patients who were performed transbronchial cryobiopsy were collected consecutively in the Japanese red cross medical center from November 2017 to May 2018. The attending physician determined whether or not the cryobiopsy is necessary for diagnosis.
Key exclusion criteria	Patients who are not tolerable for bronchoscopy
Target sample size	50

Research contact person
Name of lead principal investigator	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22 Hiroo Shibuya-ku Tokyo 150-8935, Japan
TEL	+81-3-3400-1311
Email	drtake1118@gmail.com

Public contact
Name of contact person	Naoyuki Kuse
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22 Hiroo Shibuya-ku Tokyo 150-8935, Japan
TEL	+81-3-3400-1311
Homepage URL
Email	nao-k-u@nms.ac.jp

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	日本赤十字社医療センター （東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 05 Day
Anticipated trial start date	2018 Year 06 Month 06 Day
Last follow-up date	2018 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We conducted a retrospective review from November 2017 to May 2018.

Management information
Registered date	2018 Year 06 Month 05 Day
Last modified on	2018 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037454