UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033974 |
|---|---|
| Receipt number | 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 12:13:41 |
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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
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
gotou-akt@umin.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038746
