UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023939 |
|---|---|
| Receipt number | R000026990 |
| Scientific Title | Preoperative bronchoscopic marking using virtual bronchoscopic navigation to improve surgical precision for small lung nodules |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2018/03/08 10:52:25 |
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Basic information
Public title
Preoperative bronchoscopic marking using virtual bronchoscopic navigation to improve surgical precision for small lung nodules
Acronym
Accurate preoperative bronchoscopic marking for small lung nodules
Scientific Title
Preoperative bronchoscopic marking using virtual bronchoscopic navigation to improve surgical precision for small lung nodules
Scientific Title:Acronym
Accurate preoperative bronchoscopic marking for small lung nodules
Region
| Japan |
Condition
Condition
Small lung nodules
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of endobronchial marking on lung surface with ICG and contrast agent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy and visibility of markings.
Key secondary outcomes
the rate of complete resection of small lung nodules.
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Using bronchoscopy, a catheter was inserted into a selected bronchus close to the pleura. 1 mL of dye (ICG, contrast agent) was injected. This was used as references in the subsequent operation to secure complete resection of small lung nodules. This study includes no control group.
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
Among patients who will undergo surgery at Thoracic Surgery, Kyoto University Hospital, those who clinically needs preoperative marking.
Key exclusion criteria
1 ) Patients with history of allergy to ICG, or contrast agent.
2 ) patients with bronchial asthma .
3 ) Minors and dementia patients.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyofumi F. Chen-Yoshikawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Thoracic Surgery
Zip code
Address
54 Shogoin Kawahara-cho, Sakyoku, Kyoto
TEL
075-751-4975
fengshic@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyofumi F. Chen-Yoshikawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Thoracic Surgery
Zip code
Address
54 Shogoin Kawahara-cho, Sakyoku, Kyoto
TEL
075-751-4975
Homepage URL
fengshic@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Thoracic Surgery,
Graduate School of Medicine,
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Thoracic Surgery,
Graduate School of Medicine,
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
京都大学医学部附属病院（京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 01 | 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
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 05 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026990
