UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the diagnostic accuracy for pleural adhesion using dynamic-ventilation CT
Acronym	Diagnosis of pleural adhesion using dynamic-ventilation CT
Scientific Title	Investigation of the diagnostic accuracy for pleural adhesion using dynamic-ventilation CT
Scientific Title:Acronym	Diagnosis of pleural adhesion using dynamic-ventilation CT
Region	Japan

Condition
Condition	pleural adhesion
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the diagnostic accuracy of dynamic-ventilation CT under free breathing for detecting pleural adhesions, which cannot be correctly diagnosed by conventional chest CT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy of dynamic-ventilation CT for detecting pleural adhesions around the operated lung, which are observed by thoracic surgeons at surgical operation.
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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Additional dynamic-ventilation CT (single time only)
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	1. Patients who will receive surgical operation for thoracic diseases 2. Patients who will undergo chest CT for preoperative assessment 3. Patients who are at the age of 20 or older.
Key exclusion criteria	1. Patients under 20 years-old or those who do not give written informed consent. 2. Patients who cannot follow breathing directions by radiologic technologists at scanning. 3. Patients who have any medical devices (i.e. chest tube) that are inserted in the observed pleural cavity. 4. Patients who have any metallic devices (i.e. pacemaker) in the thorax.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Tsuneo Middle name Last name Yamashiro
Organization	University of the Ryukyus
Division name	Radiology
Zip code	9030125
Address	207 Uehara, Nishihara, Okinawa 903-0215, Japan
TEL	0988951162
Email	clatsune@yahoo.co.jp

Public contact
Name of contact person	1st name Tsuneo Middle name Last name Yamashiro
Organization	University of the Ryukyus
Division name	Radiology
Zip code	9030125
Address	207 Uehara, Nishihara, Okinawa 903-0215, Japan
TEL	0988951162
Homepage URL
Email	clatsune@yahoo.co.jp

Sponsor
Institute	University of the Ryukyus
Institute
Department

Funding Source
Organization	Department of Radiology, University of the Ryukyus
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	Institutional Review Board of the University of the Ryukyus
Address	1 Senbaru, Nishihara, Okinawa
Tel	098-895-8016
Email	knknkyu@acs.u-ryukyu.ac.jp

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	琉球大学医学部附属病院（沖縄県）、滋賀医科大学医学部附属病院（滋賀県）、大阪大学医学部附属病院（大阪府）、大原綜合病院・大原医療センター（福島県）、神奈川県立循環器呼吸器病センター（神奈川県）、産業医科大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 15 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	85
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	Terminated
Date of protocol fixation	2017 Year 10 Month 10 Day
Date of IRB	2017 Year 10 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Terminated on UMIN for migration to jRCT system(jRCTs072180070, Apr 1st, 2019)

Management information
Registered date	2017 Year 11 Month 04 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033038