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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001766
Receipt No. R000002119
Scientific Title Narrow Band Imaging Applied to Pleuroscopy for the Assessment of Vascular Patterns of Pleura
Date of disclosure of the study information 2009/03/11
Last modified on 2009/11/11

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Basic information
Public title Narrow Band Imaging Applied to Pleuroscopy for the Assessment of Vascular Patterns of Pleura
Acronym Narrow Band Imaging for Pleuroscopy
Scientific Title Narrow Band Imaging Applied to Pleuroscopy for the Assessment of Vascular Patterns of Pleura
Scientific Title:Acronym Narrow Band Imaging for Pleuroscopy
Region
Japan

Condition
Condition pleural effusion of unknown etiology
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of NBI applied to pleuroscopy for detecting malignant lesions by assessing vascular patterns of pleura.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes diagnostic yield.
Key secondary outcomes Whether NBI can distinguish malignant pleural lesions from benign lesions.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic images obtained by NBI.
Interventions/Control_2 Endoscopic images obtained by white light.
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 Over 20 years of age, and ability to understand and sign informed consent forms.
Key exclusion criteria Inability to tolerate pleuroscopy under local anesthesia, such as Eastern Cooperative Oncology Group (ECOG) PS 4, inadequate lung function parameters (PaCO2>55 mmHg, PaO2<60 mmHg), uncontrolled bleeding tendency, and severe heart failure.
Target sample size 50

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 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko Ishida
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 044-977-8111
Homepage URL
Email atsuko-i@do3.enjoy.ne.jp

Sponsor
Institute St Marianna University School of Medicine
Institute
Department

Funding Source
Organization St Marianna University School of Medicine
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
2009 Year 03 Month 11 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
2006 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 05 Month 01 Day
Date analysis concluded
2009 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 11 Day
Last modified on
2009 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002119

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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