UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter observation study for the incidence of pulmonary vein stump thrombosis after pulmonary resection
Title of the study (Brief title)	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	Kenji Suzuki
Organization	Juntendo University School of Medicine
Division name	Department of General Thoracic Surgery
Address	1-3, Hongo-3-chome, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Email	kjsuzuki@juntendo.ac.jp

Public contact
Name of contact person	Aritoshi Hattori
Organization	Juntendo University School of Medicine
Division name	Department of General Thoracic Surgery
Address	1-3, Hongo-3-chome, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Homepage URL
Email	ahattori@juntendo.ac.jp

Sponsor
Institute	Department of General Thoracic Surgery, Juntendo University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 02 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031074