UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Endoleak remains or not six months later

Key secondary outcomes

The change in diameter of aneurysm

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Keio University Hospital Department of Surgery

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

10

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

10

Month

22

Day

Last modified on

2018

Year

04

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016908