UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	localization of small-sized pulmonary nodules by thoracic ultrasound during thoracic surgery
Title of the study (Brief title)	localization of small-sized pulmonary nodules by thoracic ultrasound during thoracic surgery
Region	Japan

Condition
Condition	pulmonary nodules
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	improve surgical procedure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	detection of nodule
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	intrathoracic ultrasound
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	the patients taking pulmonary resection
Key exclusion criteria	N/A
Target sample size	200

Research contact person
Name of lead principal investigator	Takashi Anayama
Organization	Kochi Medical School, Kochi university
Division name	Department of surgery II
Address	Kohasu okocho Nankoku
TEL	088-880-2375
Email	anayamat@kochi-u.ac.jp

Public contact
Name of contact person	Takashi Anayama
Organization	Kochi medical school, kochi university
Division name	Deparment of surgery II
Address	Kohau Okocho Nankoku
TEL	088-880-2375
Homepage URL
Email	anayamat@kochi-u.ac.jp

Sponsor
Institute	Depertment of surgery II, Kochi Medical School, Kochi University
Institute
Department

Funding Source
Organization	Kochi University
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 26 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2013 Year 03 Month 28 Day
Anticipated trial start date	2013 Year 03 Month 28 Day
Last follow-up date	2015 Year 11 Month 20 Day
Date of closure to data entry	2017 Year 05 Month 01 Day
Date trial data considered complete	2017 Year 05 Month 01 Day
Date analysis concluded	2017 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The ultrasound spectrum of lung cancer was different from that of normal lung tissue with statistical significance.
Other related information

Management information
Registered date	2016 Year 09 Month 26 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027831