UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011575 |
|---|---|
| Receipt number | R000013541 |
| Scientific Title | Rapid Pleurodesis is Associated with Better Results in Patients with Malignant Pleural Effusions: A Prospective Randomized Controlled Trial |
| Date of disclosure of the study information | 2013/08/25 |
| Last modified on | 2013/08/25 18:49:04 |
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Basic information
Public title
Rapid Pleurodesis is Associated with Better Results in Patients with Malignant Pleural Effusions: A Prospective Randomized Controlled Trial
Acronym
Rapid pleurodesis in malignant pleural effusions
Scientific Title
Rapid Pleurodesis is Associated with Better Results in Patients with Malignant Pleural Effusions: A Prospective Randomized Controlled Trial
Scientific Title:Acronym
Rapid pleurodesis in malignant pleural effusions
Region
| Europe |
Condition
Condition
Malignant pleural effusion
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the benefit of a rapid and effective pleurodesis method using talc in patients with potentially recurrent pleural effusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The effectiveness of pleurodesis. The rate of recurrence.
Key secondary outcomes
Hospital stay and survival of patients
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional pleurodesis
Interventions/Control_2
Rapid pleurodesis
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
histologically and/or cytologically proven malignant pleural effusion
Key exclusion criteria
Treated with simple drainage
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Serkan Ozkul |
Organization
Istanbul University Cerrahpasa Medical Faculty
Division name
Department of Thoracic Surgery
Zip code
Address
Cerrahpasa Tip Fakultesi Cerrahi Bilimler Binası, 2. Kat, Göğüs Cerrahisi
TEL
+902124143347
drserkanozkul@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akif Turna |
Organization
Istanbul University Cerrahpasa Medical Faculty
Division name
Department of Thoracic Surgery
Zip code
Address
Cerrahpasa Tip Fakultesi Cerrahi Bilimler Binasi, kat2, Gogus cerrahisi servisi
TEL
+902124143547
Homepage URL
akif.turna@gmail.com
Sponsor or person
Institute
Istanbul University Cerrahpasa Medical Faculty Department of Thoracic Surgery
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Turkey
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
Istanbul University, Cerrahpasa University Hospital, Thoracic Surgery Clinic, Istanbul
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 25 | 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
| 2011 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 25 | Day |
Last modified on
| 2013 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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