UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027118 |
|---|---|
| Receipt number | R000031074 |
| Scientific Title | Multicenter observation study for the incidence of pulmonary vein stump thrombosis after pulmonary resection |
| Date of disclosure of the study information | 2017/04/24 |
| Last modified on | 2017/04/24 22:59:34 |
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Basic information
Public title
Multicenter observation study for the incidence of pulmonary vein stump thrombosis after pulmonary resection
Acronym
Multicenter observation study for the incidence of pulmonary vein stump thrombosis after pulmonary resection
Scientific Title
Multicenter observation study for the incidence of pulmonary vein stump thrombosis after pulmonary resection
Scientific Title:Acronym
Multicenter observation study for the incidence of pulmonary vein stump thrombosis after pulmonary resection
Region
| Japan |
Condition
Condition
Lung cancer, Metastatic lung tumor, and others
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence and the favorite site of pulmonary vein stump thrombosis after pulmonary resection
Basic objectives2
Others
Basic objectives -Others
To investigate the incidence of cerebral infarction after pulmonary resection
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of pulmonary vein stump thrombosis after pulmonary resection
Key secondary outcomes
The incidence of cerebral infarction after pulmonary resection
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. Any cases performed lobectomy or more, left upper division segmentectomy and left lingular segmentectomy.
3. Patients with 20 years and over.
4. Good performance status (PS 0 or 1).
5. Informed consent.
Key exclusion criteria
1. Contrast media allergy.
2. Chronic renal failure (Cr 1.2 mg/dl and over).
3. Uncontrolled asthma.
4. Diabetes mellitus using biguanide-based medicine.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Suzuki |
Organization
Juntendo University School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
Address
1-3, Hongo-3-chome, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
kjsuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aritoshi Hattori |
Organization
Juntendo University School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
Address
1-3, Hongo-3-chome, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ahattori@juntendo.ac.jp
Sponsor or person
Institute
Department of General Thoracic Surgery, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2017 | Year | 04 | Month | 24 | 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
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter observation study for the incidence of pulmonary vein stump thrombosis after lung resection
Management information
Registered date
| 2017 | Year | 04 | Month | 24 | Day |
Last modified on
| 2017 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031074
