UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028971 |
|---|---|
| Receipt number | R000033149 |
| Scientific Title | Early chest tube removal after thoracoscopic lobectomy for lung cancer: A prospective multi-institutional study |
| Date of disclosure of the study information | 2017/09/04 |
| Last modified on | 2017/09/02 12:42:29 |
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Basic information
Public title
Early chest tube removal after thoracoscopic lobectomy for lung cancer: A prospective multi-institutional study
Acronym
Early chest tube removal after thoracoscopic lobectomy
Scientific Title
Early chest tube removal after thoracoscopic lobectomy for lung cancer: A prospective multi-institutional study
Scientific Title:Acronym
Early chest tube removal after thoracoscopic lobectomy
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the safety of early chest tube removal after thoracoscopic lobectomy for lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events after early chest tube removal
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Chest tube removal on postoperetive day 1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.A case that a document agreement by the examination participation
2.Patients with Eastern Cooperative Oncology Group performance status 0-2
3.Patients with suspected or histologically documented lung cancer
4.Consecutive patients for whom the preoperative intention was to perform a thoracoscopic anatomic pulmonary resection including a lobectomy or bilobectomy
5.Patients radiologically suspected of limited single-station N2 disease
6.Patients with preoperative stage IV, only treatable brain metastasis
Key exclusion criteria
1.Patients who underwent pneumonectomy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Nakanishi |
Organization
Nagoya City University Hospital
Division name
Department of thoracic surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8231
ryoichi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Nakanishi |
Organization
Nagoya City University Hospital
Division name
Department of thoracic surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8231
Homepage URL
ryoichi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Federation of National Public Service Personnel Mutual Aid Associations
Institute
Department
Personal name
Funding Source
Organization
Federation of National Public Service Personnel Mutual Aid Associations
Organization
Division
Category of Funding Organization
Government offices of other countries
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
国家公務員共済組合連合会 新小倉病院・浜ノ町病院・新別府病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 04 | 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
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 02 | Day |
Last modified on
| 2017 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033149
