UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of safety and efficacy of bronchoscope biopsy with a Cryoprobe.
Title of the study (Brief title)	A study of safety and efficacy of bronchoscope biopsy with a Cryoprobe.
Region	Japan

Condition
Condition	Lung tumor, Diffuse interstitial lung disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of bronchoscope biopsy with a Cryoprobe.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Ratio of the trachea and the bronchus severe bleeding to need for additional intervention, e.g. instillation of ice-cold saline or a diluted vasoconstrictive drug, balloon tamponade, argon plasma coagulation, conversion to rigid bronchoscopy or mechanical ventilation.
Key secondary outcomes	Ratio of the trachea and the bronchus mild or moderate bleeding Adverse events except the trachea and the bronchus bleeding Definitive diagnosis ratio Size of the specimen (e.g., longer axis, minor axis, area) on pathologic review. Exploratory examination about relations of the pneumothorax and distance between Cryoprobe and the pleura.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Bronchoscope biopsy with a Cryoprobe
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) In chest CT, the following diseases have been already diagnosed or is suspected; the patient who needs transbronchial biopsy using bronchoscope. 1: Primary lung cancer 2: Metastatic lung cancer 3: Diffuse interstitial lung disease 2) Age 20 to 80 years 3) ECOG Performance status of 0, 1, or 2 4) Adequate organ function, as - Absolute neutrophil count > or = 1,500/mm3 - Hemoglobin > or = 9.0g/dL - Platelet count > or = 10x10,000/mm3 - AST and ALT < or = 100 IU/L - Total bilirubin level < or = 1.5mg/dL - Serum creatinine level < or = 1.5mg/dL - Prothrombin time-International normalized ratio < or = 1.5 - Oxygen saturation (Room air) > or = 90% - Forced expiratory volume in 1 second > or = 1.0L 5) Written informed consent
Key exclusion criteria	1) Serious hypersensitivity to lidocaine, midazolam, pethidine hydrochloride or other drugs. 2) Using antiplatelet or anticoagulation therapy (an appropriate discontinuation period is necessary). 3) Current or previous history of continuing bloody sputum (>1 tea spoon) within one month. 4) Evidence of tumor invading the hilum of lung, a heart, and major blood vessels on imaging. 5) Severe complications (e.g., uncontrollable peptic ulcer, gastrointestinal bleeding, angina pectoris, cardiovascular disease, or infection) 6) Severe infections 7) Pregnancy, breast feeding and suspected pregnancy. 8) Inappropriate for this study judged by the attending doctor
Target sample size	150

Research contact person
Name of lead principal investigator	Taichi Mochizuki
Organization	International University of Health and Welfare, Mita hospital
Division name	Respiratory Disease Center
Address	1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL	03-3451-8121
Email	t-mochi@iuhw.ac.jp

Public contact
Name of contact person	Seisuke Nagase
Organization	International University of Health and Welfare, Mita hospital
Division name	Respiratory Disease Center
Address	1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL	03-3451-8121
Homepage URL
Email	snagase@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare, Mita hospital
Institute
Department

Funding Source
Organization	International University of Health and Welfare, Mita hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	国際医療福祉大学三田病院　呼吸器センター (東京都)

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 18 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 13 Day
Anticipated trial start date	2018 Year 10 Month 20 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 17 Day
Last modified on	2018 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039379