UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective observational study: the utility of flex-rigid pleuroscopy for malignant pleural disease
Title of the study (Brief title)	Pleuroscopy prospective observational study
Region	Japan

Condition
Condition	malignant pleural disease
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of flex-rigid pleuroscopy for malignant pleural disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	diagnostic yield
Key secondary outcomes	1) safety 2) feasibility of molecular analysis

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	20 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Cases that is suspected to have pleural malignant disease by computed tomography (CT) 2) Cases that is required re-biopsy and tissue specimen for the recurrence of pleural malignant disease 3) Obtained comprehensive agreement for study
Key exclusion criteria	1) without CT before pleuroscopy 2) with severe pleural adhesions 3) severe respiratory failure of the contralateral lung 4) cases that can not quietly lie 5) SpO2 less than 90% 6) uncontrolled condition such as angina, myocardial infraction, severe bronchial asthmna, active lung infection, heart failure, bleeding tendency, and so on 7) during pregnancy 8) anticoagulants or antiplatelet agents can not be stopped for 3 days or more 9) difficult to get agreement by the document 10) other inappropriate reasons
Target sample size	25

Research contact person
Name of lead principal investigator	Toshiyuki Nakai
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Address	5-1-1, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	tnakai@ncc.go.jp

Public contact
Name of contact person	Toshiyuki Nakai
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Address	5-1-1, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	tnakai@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	The National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 09 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 04 Day
Anticipated trial start date	2016 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To evaluate the efficacy of flex-rigid pleuroscopy for malignant pleural disease

Management information
Registered date	2016 Year 09 Month 26 Day
Last modified on	2016 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027829