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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003926
Receipt No. R000004719
Scientific Title Talc pleurodesis through flexi-rigid thoracoscope under local anesthesia
Date of disclosure of the study information 2010/07/19
Last modified on 2011/07/20

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Basic information
Public title Talc pleurodesis through flexi-rigid thoracoscope under local anesthesia
Acronym Talc pleurodesis through flexi-rigid thoracoscope under local anesthesia
Scientific Title Talc pleurodesis through flexi-rigid thoracoscope under local anesthesia
Scientific Title:Acronym Talc pleurodesis through flexi-rigid thoracoscope under local anesthesia
Region
Japan

Condition
Condition uncontrolled and symptomatic pleural effusion
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For pleurodesis, talc administered by poudrage has to be insufflated blindly from a single port of entry when using the standard method with a small-diameter rigid thoracoscope. In order to perform talc poudrage under visual control from a single port, we introduced a catheter technique through a flexi-rigid thoracoscope, and assessed its safety and usefulness in a pilot study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In order to insufflate talc into the pleural cavity under visualization, the catheter was connected to a talc atomizer and inserted through the working channel of the flexi-rigid thoracoscope. A bronchoscopic guide sheath with a 2.1-mm inner diameter was used as a catheter.
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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We included patients aged > 20.
Key exclusion criteria We excluded those considered unable to tolerate thoracoscopy, such as having inadequate lung function parameters, uncontrolled bleeding tendency and severe heart failure.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruomi Miyazawa
Organization St. Marianna University School of Medicine
Division name Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization St. Marianna University School of Medicine
Division name Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
TEL 044-977-8111
Homepage URL
Email

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization none
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
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
2010 Year 07 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

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
2005 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 11 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 Interact Cardiovasc Thorac Surg 2011; 12: 667-670.

Management information
Registered date
2010 Year 07 Month 19 Day
Last modified on
2011 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004719

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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