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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025510
Receipt No. R000029361
Scientific Title VATS lobectomy under Heliox inhalation: A randomized phase 2 trial
Date of disclosure of the study information 2017/01/04
Last modified on 2018/07/07

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Basic information
Public title VATS lobectomy under Heliox inhalation: A randomized phase 2 trial
Acronym VATS lobectomy under Heliox inhalation
Scientific Title VATS lobectomy under Heliox inhalation: A randomized phase 2 trial
Scientific Title:Acronym VATS lobectomy under Heliox inhalation
Region
Japan

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

Objectives
Narrative objectives1 This study is planned to evaluate the usefulness of Heliox inhalation for the improvement of visual field in VATS lobectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Improvement of visual field during surgery
Key secondary outcomes safety, op. time, hospital stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Heliox inhalation
Interventions/Control_2 Conventional anaesthetic methods
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo VATS lobectomy
Key exclusion criteria Patients with the impossible lung collapse
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Yoshimasu
Organization Wakayama Medical University
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 811-1 Kimiidera, Wakayama
TEL 81-73-441-0615
Email yositatu@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Yoshimasu
Organization Wakayama Medical University
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 811-1 Kimiidera, Wakayama
TEL 81-73-441-0615
Homepage URL
Email yositatu@wakayama-med.ac.jp

Sponsor
Institute Department of Thoracic and Cardiovascular Surgery, Wakayama Medical University, Japan
Institute
Department

Funding Source
Organization JSPS KAKENHI
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Analysis was finished.
Under statistical power.
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 Completed
Date of protocol fixation
2016 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 06 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 04 Day
Last modified on
2018 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029361

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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