UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029822 |
|---|---|
| Receipt number | R000033038 |
| Scientific Title | Investigation of the diagnostic accuracy for pleural adhesion using dynamic-ventilation CT |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2021/05/10 19:19:44 |
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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
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
clatsune@yahoo.co.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033038
