UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037863 |
|---|---|
| Receipt number | R000043171 |
| Scientific Title | Clinical research regarding observation of bronchial wall after pulmonary resection with Linked Color Imaging (LCI) |
| Date of disclosure of the study information | 2019/08/30 |
| Last modified on | 2024/03/18 11:13:18 |
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Basic information
Public title
Clinical research regarding observation of bronchial wall after pulmonary resection with Linked Color Imaging (LCI)
Acronym
Clinical research regarding observation of bronchial wall after pulmonary resection with Linked Color Imaging (LCI)
Scientific Title
Clinical research regarding observation of bronchial wall after pulmonary resection with Linked Color Imaging (LCI)
Scientific Title:Acronym
Clinical research regarding observation of bronchial wall after pulmonary resection with Linked Color Imaging (LCI)
Region
| Japan |
Condition
Condition
malignant lung tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the method for diagnosis of postoperative ischemic bronchitis with bronchoscopy having Linked Color Imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the presence of postoperative ischemic bronchitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We will perform bronchoscopy once after pulmonary resection.
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
Patients who require bronchoscopy after lobectomy or segmentectomy for malignant lung tumor and can get their concent
Key exclusion criteria
Patients who cannot get their concent
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Jichi Medical University
Division name
Division of General Thoracic Surgery, Department of Surgery
Zip code
3290498
Address
3311-1, Yakushiji, Simotsuke, Tochigi, Japan
TEL
0285587368
tcvyamap@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Jichi Medical University
Division name
Division of General Thoracic Surgery, Department of Surgery
Zip code
3290498
Address
3311-1, Yakushiji, Simotsuke, Tochigi, Japan
TEL
0285587368
Homepage URL
tcvyamap@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Jichi Medical University
Address
Division of General Thoracic Surgery, Department of Surgery
Tel
0285588933
rinri@jichi.ac.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 | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | 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
Management information
Registered date
| 2019 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043171
