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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009661
Receipt No. 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

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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
Email 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
Email dr-ryo@kanazawa-med.ac.jp

Sponsor
Institute Department of Thoracic Surgery, Kanazawa Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011336

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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