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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034546
Receipt No. R000039379
Scientific Title A study of safety and efficacy of bronchoscope biopsy with a Cryoprobe.
Date of disclosure of the study information 2018/10/18
Last modified on 2018/10/24

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Basic information
Public title A study of safety and efficacy of bronchoscope biopsy with a Cryoprobe.
Acronym A study of safety and efficacy of bronchoscope biopsy with a Cryoprobe.
Scientific Title A study of safety and efficacy of bronchoscope biopsy with a Cryoprobe.
Scientific Title:Acronym 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
1st name
Middle name
Last name Taichi Mochizuki
Organization International University of Health and Welfare, Mita hospital
Division name Respiratory Disease Center
Zip code
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
1st name
Middle name
Last name Seisuke Nagase
Organization International University of Health and Welfare, Mita hospital
Division name Respiratory Disease Center
Zip code
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

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 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

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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 13 Day
Date of IRB
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

Other
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

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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