UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034546 |
|---|---|
| Receipt number | 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 10:59:39 |
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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
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
snagase@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, Mita hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039379
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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