UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009661 |
|---|---|
| Receipt number | R000011336 |
| Scientific Title | A randomized trial to compare the single or double chest tube applications after pulmonary lobectomy |
| Date of disclosure of the study information | 2012/12/29 |
| Last modified on | 2018/01/04 10:40:56 |
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Basic information
Public title
A randomized trial to compare the single or double chest tube applications after pulmonary lobectomy
Acronym
A randomized trial to compare the single or double chest tube applications after pulmonary lobectomy
Scientific Title
A randomized trial to compare the single or double chest tube applications after pulmonary lobectomy
Scientific Title:Acronym
A randomized trial to compare the single or double chest tube applications after pulmonary lobectomy
Region
| Japan |
Condition
Condition
Postsurgical state after pulmonary lobectomy
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to compare the clinical course after pulmonary lobectomy + mediastinal nodal dissection with one chest tube and with two chest tubes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
necessity of thoracentesis
Key secondary outcomes
amount of drainage fluid, duration of drainage, patients' pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To place one chest tube after pulmonary lobectomy (PD1)
Interventions/Control_2
To place two chest tubes after pulmonary lobectomy (PD2)
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
After lobectomy or bilobectomy
After mediastinal nodal dissection (
at least 50%)
Key exclusion criteria
After pneumonectomy
In the condition where massive air leakage or massive bleeding is expected
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyasu Sagawa |
Organization
Kanazawa Medical University
Division name
Department of Thoracic Surgery
Zip code
Address
1-1 Daigaku, Uchinada, Isikawa 920-0293, Japan
TEL
076-286-1207
sagawam@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Tanaka |
Organization
Kanazawa Medical University
Division name
Department of Thoracic Surgery
Zip code
Address
1-1 Daigaku, Uchinada, Isikawa 920-0293, Japan
TEL
076-286-1207
Homepage URL
dr-ryo@kanazawa-med.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
the Grant-in-Aid for Scientific Research from the Ministry of Health, Labour and Welfare, and from the Ministry of Education, Culture, Sports, Science and Technology, Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/tjem/232/1/232_55/_pdf/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/tjem/232/1/232_55/_pdf/-char/en
Number of participants that the trial has enrolled
Results
A total of 108 patients were registered in the study. There were no significant differences in the age, gender, pathological stage or histological type between two groups. Since the residual lung expansion was good in both groups, there were no patients who needed thoracentesis. There were no significant differences in the number of cases with pleurodesis, the amount/duration of drainage or the pain of the patients between two groups. Since PD1 has advantages in saving cost and time and in low risk of transcutaneous infection, PD1 is appropriate after pulmonary lobectomy by VATS and by open thoracotomy.
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 | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | 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
| 2012 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011336
