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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036921
Receipt No. R000042073
Scientific Title Efficacy of intraoperative ultrasonography for the detection of small lung nodules
Date of disclosure of the study information 2019/06/02
Last modified on 2019/06/02

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Basic information
Public title Efficacy of intraoperative ultrasonography for the detection of small lung nodules
Acronym Efficacy of intraoperative ultrasonography for the detection of small lung nodules
Scientific Title Efficacy of intraoperative ultrasonography for the detection of small lung nodules
Scientific Title:Acronym Efficacy of intraoperative ultrasonography for the detection of small lung nodules
Region
Japan

Condition
Condition lung cancer, metastatic lung tumor, benign lung nodule
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the intrathoracic pressure and ultrasound setting suitable for performing intraoperative ultrasonography for lung nodules, and to examine the usefulness of intraoperative ultrasonographic lung puncture marking
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes detection of lung nodules under intraoperative ultrasonography during surgery
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 To perform intraoperative ultrasonography to identify pulmonary nodules in the thoracic cavity under positive thoracic pressure
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) lung nodules less than 20mm, which is planned for lung wedge resection
2) palpation with small thoracotomy requires site identification normally
3) ECOG = 0-1
4) following data criteria is met:
WBC 3,000-12,000/mm3
Hemoglobin more than 9.0g/dl
Platelet more than 10x104/mm3
AST less than 100IU/L, ALT less than 100IU/L
Total Bilirubin less than 1.5mg/dL
serum Creatinine less than 1.5mg/dL
Key exclusion criteria 1) cases where it may be difficult to identify even by palpation with small thoracotomy if it is not possible to visualize by intraoperative ultrasonography.
2) High-risk patients who can not tolerate extended general anesthesia
3) Patients with interstitial pneumonia
4) Patients with emphsematous change
5) Patients that the attending physician judged inappropriate to carry out this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoshikane
Middle name
Last name Yamauchi
Organization Teikyo University School of medicine
Division name Department of Surgery
Zip code 1738605
Address Kaga 2-11-1, Itabashi, Tokyo
TEL +81339641211
Email yoshikaney@2004.jukuin.keio.ac.jp

Public contact
Name of contact person
1st name Yoshikane
Middle name
Last name Yamauchi
Organization Teikyo University School of medicine
Division name Department of Surgery
Zip code 1738605
Address Kaga 2-11-1, Itabashi, Tokyo
TEL +81339641211
Homepage URL
Email yoshikaney@2004.jukuin.keio.ac.jp

Sponsor
Institute Department of Surgery, Teikyo University School of medicine
Institute
Department

Funding Source
Organization Teikyo 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 Teikyo University Ethics comittee
Address Kaga 2-11-1, Itabashi, Tokyo
Tel +81 3 3964 7256
Email turb-office@teikyo-u.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 帝京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 02 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 20
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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
2016 Year 08 Month 15 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 02 Day
Last modified on
2019 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042073

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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