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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033974
Receipt No. R000038746
Scientific Title A phase I trial examining the safety of major left lung resection with left atrial appendectomy for left lung cancer patients with atrial fibrillation
Date of disclosure of the study information 2018/09/03
Last modified on 2019/02/28

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Basic information
Public title A phase I trial examining the safety of major left lung resection with left atrial appendectomy for left lung cancer patients with atrial fibrillation
Acronym A phase I trial examining the safety of major left lung resection with left atrial appendectomy
Scientific Title A phase I trial examining the safety of major left lung resection with left atrial appendectomy for left lung cancer patients with atrial fibrillation
Scientific Title:Acronym A phase I trial examining the safety of major left lung resection with left atrial appendectomy
Region
Japan

Condition
Condition malignant tumor of the lung
atrial fibrillation
Classification by specialty
Cardiology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the safety of major left lung resection with left atrial appendectomy for left lung cancer patients with non-valvular atrial fibrillation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events rate
Key secondary outcomes Operative time
Bleeding volume
length of drainage tube placement
length of hospital stay

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 are scheduled for surgery for left malignant pulmonary tumor (suspected or confirmed)
2.surgical procedure: segmentectomy >=
3.non-valvular atrial fibrillation
4.20 years <=
5.ECOG performance status of 0 or 1
6. No following surgical history
i) left thoracotomy
ii) left thoracoscopic resection of lung, esophagus, and mediastinum (except for thoracoscopic resection of bullae)
iii) Heart and great vessel surgery (except for thoracic endovascular aortic repair)
7.Written informed consent
Key exclusion criteria 1.Active infection requiring systemic therapy
2. Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy
3.Severe psychological disorder
4.History of myocardial infarction or attack of angina pectoris within the past 3 weeks
5.Uncontrollable valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy
6.Interstitial pneumonitis
7.thrombus in left atrial appendage
8.No radiotherapy at the site of operation
9. a participating surgeon judged that the patient was not appropriate candidate for the study
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Tuchida
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Thoracic and Cardiovascular Surgery
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata
TEL 025-227-2243
Email masatsu@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Goto
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Thoracic and Cardiovascular Surgery
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata
TEL 025-227-2243
Homepage URL
Email gotou-akt@umin.ac.jp

Sponsor
Institute Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Division of Thoracic and Cardiovascular Surgery, Niigata University Graduate School of Medical and Dental Sciences
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 03 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Adverse events
Operative time
Bleeding volume
length of drainage tube placement
length of hospital stay

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038746

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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