UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061540 |
|---|---|
| Receipt number | R000070418 |
| Scientific Title | A Retrospective Study of the Relationship Between Chest Tube Placement and Pleurodesis Success |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/05/12 17:29:22 |
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Basic information
Public title
A Retrospective Study of the Relationship Between Chest Tube Placement and Pleurodesis Success
Acronym
A Retrospective Study of the Relationship Between Chest Tube Placement and Pleurodesis Success
Scientific Title
A Retrospective Study of the Relationship Between Chest Tube Placement and Pleurodesis Success
Scientific Title:Acronym
A Retrospective Study of the Relationship Between Chest Tube Placement and Pleurodesis Success
Region
| Japan |
Condition
Condition
Malignant pleural effision
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of chest tube placement on pleurodesis success in patients with malignant pleural effusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of pleurodesis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who underwent talc slurry-based pleurodesis for malignant pleural effusion between April 2015 and December 2024.
Key exclusion criteria
Patients were excluded if they: (1) had previously undergone chemical pleurodesis on the ipsilateral thorax; (2) underwent prophylactic pleurodesis (it means they were asymptomatic and had pleural fluid confined below the dome of the diaphragm); (3) had a radiologically significant (>25%) non-expandable lung; (4) did not undergo lateral chest X-ray assessment, and therefore the chest tube position was unknown; (5) developed empyema during the treatment; (6) underwent repeat pleurodesis before the chest tube removal; (7) did not undergo any radiological assessment beyond 1 week after pleurodesis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Nishikubo |
Organization
Hyogo Cancer Center
Division name
Division of Chest Surgery
Zip code
673-0021
Address
13-70 Kitaoji-cho, Akashi City, Hyogo, Japan
TEL
+81-78-929-1151
megumis0512@gmail.com
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Nishikubo |
Organization
Hyogo Cancer Center
Division name
Division of Chest Surgery
Zip code
673-0021
Address
13-70 Kitaoji-cho, Akashi City, Hyogo, Japan
TEL
+81-78-929-1151
Homepage URL
megumis0512@gmail.com
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Cancer Center
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
Clinical Research Area Ethics Committee of the Hyogo Cancer Center
Address
13-70 Kitaoji-cho, Akashi City, Hyogo, Japan, 673-0021
Tel
078-929-1151
hcc-rinri@hyogo-cc.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
| 2026 | Year | 05 | Month | 12 | 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
160
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the success rate of pleurodesis. Success was defined as no pleural fluid re-accumulation greater than that seen on the baseline CXR or no requirement for further pleural intervention on the ipsilateral side.
Management information
Registered date
| 2026 | Year | 05 | Month | 12 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070418
