UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks in endovascular repair of thoracic aortic aneurysms
Title of the study (Brief title)	The relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks in endovascular repair of thoracic aortic aneurysms
Region	Japan

Condition
Condition	thoracic aortic aneurysms
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine that the effectiveness of the detection of persistent endoleaks by spontaneous echocardiographic contrast within the aneurysm in endovascular repair of thoracic aortic aneurysms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Persistent endoleaks at follow-up CT imaging
Key secondary outcomes	Persistent endoleaks at postoperative CT imaging Need for additional intervention

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	Patients undergoing thoracic endovascular aortic repair
Key exclusion criteria	Patients with contraindication to transesophageal echocardiography
Target sample size	70

Research contact person
Name of lead principal investigator	Hidekazu Imai
Organization	Niigata University Medical and Dental Hospital
Division name	Department of Anesthesiology
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL	025-227-2328
Email	hdkzimi@med.niigata-u.ac.jp

Public contact
Name of contact person	Hidekazu Imai
Organization	Niigata University Medical and Dental Hospital
Division name	Department of Anesthesiology
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL	025-227-2328
Homepage URL
Email	hdkzimi@med.niigata-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Niigata University Medical and Dental Hospital
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	新潟大学医歯学総合病院（新潟県）

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 01 Day
Anticipated trial start date	2010 Year 07 Month 14 Day
Last follow-up date	2014 Year 02 Month 01 Day
Date of closure to data entry	2014 Year 02 Month 01 Day
Date trial data considered complete	2014 Year 02 Month 01 Day
Date analysis concluded	2014 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://journals.lww.com/anesthesia-analgesia/Abstract/2017/08000/Intraoperative_Detection_of_Persist
Results	Patients with spontaneous echocardiographic contrast had a higher incidence of postoperative endoleaks than did patients without spontaneous echocardiographic contrast within a few days postoperatively (60.0% vs 12.5%, respectively; P < 0.001) and at 6 months postoperatively (40.0% vs 2.5%, respectively; P < 0.001).
Other related information	We examine that the relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks at follow-up CT imaging in endovascular repair of thoracic aortic aneurysms.

Management information
Registered date	2012 Year 09 Month 18 Day
Last modified on	2017 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010480