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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011575
Receipt No. 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

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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 Binas&#305;, 2. Kat, G&#246;&#287;&#252;s Cerrahisi
TEL +902124143347
Email 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
Email akif.turna@gmail.com

Sponsor
Institute Istanbul University Cerrahpasa Medical Faculty Department of Thoracic Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013541

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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