UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of thin bronchoscopic cryobiopsy through a long nasobronchial tube for lung diseases
Acronym	Cryobiopsy through a nasobronchial tube
Scientific Title	Safety and efficacy of thin bronchoscopic cryobiopsy through a long nasobronchial tube for lung diseases
Scientific Title:Acronym	Cryobiopsy through a nasobronchial tube
Region	Japan

Condition
Condition	Lung diseases
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of thin bronchoscopic cryobiopsy through a long nasobronchial tube for lung diseases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Safety (frequency of bleeding)
Key secondary outcomes	1. Safety (frequency of complications other than bleeding) 2. Pathological diagnostic yield 3. Procedural duration 4. Frequency of oxygen desaturation 5. Size of specimens

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	1. Patients with lung lesions on chest CT, to whom tissue sampling by cryobiopsy is considered adequate for a pathological diagnosis. 2. >=20 years old 3. Patients who can temporarily interrupt anticoagulant/antiplatelet agents 4. Informed consent
Key exclusion criteria	1. Lesion located within the inner second ellipse from the hilum on chest CT 2. Patients who were previously enrolled in this trial 3. Patients who need to undergo a bronchoscopic procedure for a nontarget lesion in the same setting 4. Patients with large lung cysts near the biopsy site 5. Lesions near a large vessel 6. Lesions inaccessible to the cryoprobe (e.g. apical lung lesions) 7. Patients with a diffuse lung disease who are receiving steroid therapy 8. Pregnant woman 9. Bleeding tendency 10. Pulmonary hypertension 11. Serious concomitant medical illness 12. Other clinical difficulties
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Masahide Middle name Last name Oki
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Respiratory Medicine
Zip code	460-0001
Address	4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL	052-951-1111
Email	masahideo@gmail.com

Public contact
Name of contact person	1st name Masahide Middle name Last name Oki
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Respiratory Medicine
Zip code	460-0001
Address	4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL	052-951-1111
Homepage URL
Email	masahideo@gmail.com

Sponsor
Institute	National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization	None
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	The institutional review board of Nagoya Medical Center
Address	4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
Tel	052-951-1111
Email	311-rec@mail.hosp.go.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	2019 Year 06 Month 24 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	2019 Year 04 Month 10 Day
Date of IRB	2019 Year 06 Month 17 Day
Anticipated trial start date	2019 Year 06 Month 24 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study

Management information
Registered date	2019 Year 06 Month 24 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042342