UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051770 |
|---|---|
| Receipt number | R000059010 |
| Scientific Title | Randomized controlled trial for the management of air leakage after pulmonary resection |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/07/31 23:03:59 |
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Basic information
Public title
Randomized controlled trial for the management of air leakage after pulmonary resection
Acronym
Randomized controlled trial for the management of air leakage after pulmonary resection
Scientific Title
Randomized controlled trial for the management of air leakage after pulmonary resection
Scientific Title:Acronym
Randomized controlled trial for the management of air leakage after pulmonary resection
Region
| Japan |
Condition
Condition
Air leakage after pulmonary resection
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the optimal management method for the postoperative air leakage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The duration of postoperative drainage
Key secondary outcomes
The duration of postoperative air leakage
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
GroupD: Digital drainage system. Thopaz is used for chest drainage in physiological pressure mode(=-8cmH2O)
Interventions/Control_2
GroupA: Analog chest drainage system. Analog chest drainage system is used in water seal.
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
(1) The patients who underwent anatomical pulmonary resection (segmentectomy,lobectomy,and bilobectomy)
(2) The patients who have postoperative air leakage more than 30ml/min detected by thopaz on the third day after surgery
(3) The patients who consent to the includion of this study in writing
Key exclusion criteria
(1) The patients who underwent pneumonectomy
(2) The patients who underwent lung resection with bronchus or vessel plasty
(3) The patients who underwent combined resection of adjacent organs in treatment
(4) The use of positive pressure ventilation after surgery
(5) The patients who already have therapeutic interventions for postoperative air leakage before including this study
(6) The patients who are privided more than two chest drainage tubes in operation room
(7) Chylothorax or empyema is detected before including this study
(8) The volume of chest drainage is more than 300ml/day
(9) The reserch responsible doctor or investigator judges the inadequateness of including
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shintani |
Organization
Osaka University Graduate School of Medicine, Yamadaoka, Suita, Osaka, Japan
Division name
Department of General Thoracic Surgery
Zip code
5650871
Address
2-2-L5, Yamadaoka, Suita, Osaka
TEL
0668793152
yshintani@thoracic.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hiroshima |
Organization
Osaka University Graduate School of Medicine, Yamadaoka, Suita, Osaka, Japan
Division name
Department of General Thoracic Surgery
Zip code
5650871
Address
2-2-L5, Yamadaoka, Suita, Osaka
TEL
0668793152
Homepage URL
t-hiroshima@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of General Thoracic Surgery, Osaka University Graduate School of Medicine, Yamadaoka, Suita, Osaka, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of General Thoracic Surgery, Osaka University Graduate School of Medicine, Yamadaoka, Suita, Osaka, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Center for Translational Research Osaka University Hospital
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8290
rinri@hp-crc.med.osaka-u.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
| 2023 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059010
