UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change of pulmonary function after thoracoabdominal aneurysm repair
Title of the study (Brief title)	pulmonary function after thoracoabdominal aneurysm repair
Region	Japan

Condition
Condition	thoracoabdominal aneurysm
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the affection for pulmonary function after repair of the diaphragm during thoracoabdominal aneurysm repair
Basic objectives2	Others
Basic objectives -Others	the change of physiological function
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pulmonary function and the change of CT scan images
Key secondary outcomes

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	64 years-old <=
Age-upper limit	81 years-old >=
Gender	Male and Female
Key inclusion criteria	the patients with thoracoabdominal aneurysm repair
Key exclusion criteria	the patients with pulmonary function test and CT scan in inappropriate period
Target sample size	15

Research contact person
Name of lead principal investigator	Junji Nakazawa
Organization	Sapporo Medical University of Medicine
Division name	Department of Cardiovascular Surgery
Address	Hokkaido prefecture Sapporo City South 1 West 16
TEL	0116112111
Email	bankara02@chic.ocn.ne.jp

Public contact
Name of contact person	Junji Nakazawa
Organization	Sapporo Medical University of Medicine
Division name	Department of Cardiovascular Surgery
Address	Hokkaido prefecture Sapporo City South 1 West 16
TEL	0116112111
Homepage URL
Email	bankara02@chic.ocn.ne.jp

Sponsor
Institute	Sapporo Medical University of Medicine
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
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	2018 Year 07 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 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	nothing

Management information
Registered date	2018 Year 07 Month 26 Day
Last modified on	2018 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038226