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Recruitment status Terminated
Unique ID issued by UMIN UMIN000015500
Receipt No. R000016908
Scientific Title CT-guided percutaneous embolization for Type II endoleak after endovascular abdominal aortic aneurysm repair
Date of disclosure of the study information 2014/10/22
Last modified on 2018/04/12

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Basic information
Public title CT-guided percutaneous embolization for Type II endoleak after endovascular abdominal aortic aneurysm repair
Acronym CT-guided percutaneous embolization for Type II endoleak after endovascular abdominal aortic aneurysm repair
Scientific Title CT-guided percutaneous embolization for Type II endoleak after endovascular abdominal aortic aneurysm repair
Scientific Title:Acronym CT-guided percutaneous embolization for Type II endoleak after endovascular abdominal aortic aneurysm repair
Region
Japan

Condition
Condition Patients after treatment of the stent graft, who have TypeII endoleak and difficulty with transcatheter embolization
Classification by specialty
Surgery in general Vascular surgery Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of CT-guided direct puncturing and embolization for Type II endoleak after endovascular abdominal aortic aneurysm repair
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Endoleak remains or not six months later
Key secondary outcomes The change in diameter of aneurysm

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Referring to the contrast CT image taken before the procedure, the cavity with Type II endoleak is punctured directly by US needle under CT guide. After the puncture, the culprit vessel and Type II endoleak cavity is identified by angiography. Thereafter, embolization of culprit vessel and/or Type II endoleak cavity will be performed.Several nitinol coils are basically used, but if necessary,a liquid embolic material such as NBCA will be also appropriately injected into the cavity.
To evaluate the treatment effect, one month later and after that every several months at the same interval as usual examination both the effect of embolization and the change in diameter of aneurysm is determined by contrast CT, MRI, and US.
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 after treatment of the stent graft for abdominal aortic aneurysm repair, who have TypeII endoleak and difficulty with transcatheter embolization. Also anatomically we judge it enforceable to puncture them directly under CT-guide.
And it is required for them to satisfy all the following.
1) The patient who receive enough explanation of this study from his attending doctor and can understand it
2) The patient who has will to participate in this study and consent in writing by himself
3) The patient without an allergy for Xylocaine which is a local anesthetic
4) The patient without an allergy to contrast media
5) The patient we can expect have prognosis more than approximately three months, and who can tolerate the approach of this treatment
6) The patient who has a normal coagulability, who dosen't have bleeding tendency
7) The patient who is not complicated with a severe infectious disease
Key exclusion criteria 1) The patient who has abnormal coagulability and a bleeding tendency
2) The patient who has a difficulty with puncturing anatomically
3) The patient who has either a severe systemic infectious disease or an infection in the treatment local site

Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Obara
Organization Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3802
Email obara@z3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Matsubara
Organization Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3802
Homepage URL
Email matsubara@z6.keio.jp

Sponsor
Institute Keio University Hospital Department of Surgery
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 慶應義塾大学病院(東京都)
川崎市立川崎病院(神奈川県)
水戸赤十字病院(茨城県)
さいたま市立病院(埼玉県)
東京歯科大市川総合病院(千葉県)
済生会横浜市東部病院(神奈川県)
平塚市民病院(神奈川県)
済生会中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 22 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 Terminated
Date of protocol fixation
2012 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 11 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

Management information
Registered date
2014 Year 10 Month 22 Day
Last modified on
2018 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016908

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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