UMIN-CTR Clinical Trial

Public title

Outcomes of Treatment Strategies for Isolated Spontaneous Superior Mesenteric Artery Dissection: A Systematic Review

Acronym

A Systematic Review of Isolated SMA dissection

Scientific Title

Outcomes of Treatment Strategies for Isolated Spontaneous Superior Mesenteric Artery Dissection: A Systematic Review

Scientific Title:Acronym

A Systematic Review of Isolated SMA dissection

Region

Japan

Condition

Isolated spontaneous superior mesenteric artery dissection

Classification by specialty

Cardiology

Vascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to evaluate the characteristics and the treatment strategies of isolated spontaneous superior mesenteric artery dissection.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

a composite of SMA dissection-related death and the use of an additional intervention (endovascular or surgery)

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

We searched the Cochrane Library, MEDLINE, and Clinical Trial.gov databases until December 31, 2015. We retrieved articles presenting the treatment and outcomes of isolated SMA dissection.

Key exclusion criteria

Articles reporting SMA dissections that were iatrogenic or traumatic, or were associated with abdominal aortic dissection were excluded. Additionally, we excluded single-patient case reports, systematic reviews, and reports on other visceral artery dissections.

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Takao Kato

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

Address

54 Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan

TEL

+81-75-751-3190

Email

takao-kato@kitano-hp.or.jp

Name of contact person

1st name
Middle name
Last name	Yuki Kimura

Organization

Tazuke Kofukai Medical Research Institute, Kitano Hospital

Division name

Cardiovascular Center

Zip code

Address

2-4-20 Ogimachi, Kita-ku, Osaka 530-8480, Japan

TEL

+81-6-6361-0588

Homepage URL

Email

yuuki-kitano@kitano-hp.or.jp

Institute

Cardiovascular Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital

Institute

Department

Personal name

Organization

Cardiovascular Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital

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

Date of disclosure of the study information

2016

Year

09

Month

10

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.annalsofvascularsurgery.com/article/S0890-5096(17)30917-2/fulltext

Number of participants that the trial has enrolled

Results

OBJECTIVES:
Isolated spontaneous dissection of the superior mesenteric artery (SMA) without aortic dissection is being increasingly recognized. This study aimed to evaluate the latest clinical characteristics and optimal treatment.
METHODS:
We searched the Cochrane Library, MEDLINE, and Clinical Trial.gov databases through December 31, 2016, using the following words: "superior mesenteric artery" and "dissection." We retrieved articles presenting the treatment and outcomes of isolated SMA dissection published in English. We investigated the patient characteristics, treatments, follow-up, and prognoses. Additionally, we compared mortality rates and assessed the need for additional interventions between treatment strategies in symptomatic patients without accompanying proof of bowel ischaemia or aneurysm, which require immediate endovascular treatment or surgery.
RESULTS:
We identified 51 articles with 721 patients. The initial treatments in symptomatic patients without accompanying proof of bowel ischaemia or aneurysm were conservative treatment (82.1%), endovascular treatment (14.3%), catheter-directed infusion of medication (2.1%), and surgery (1.5%). Additional treatment was needed in 18.1% of patients receiving conservative treatment and 2.4% of patients receiving endovascular treatment (P = 0.0003). Mortality was not significantly different between each treatment strategy (P = 0.92).
CONCLUSIONS:
There was no significant difference in mortality of symptomatic SMA dissection patients without accompanying proof of bowel ischaemia or aneurysm between interventional treatment and conservative treatment. An additional treatment is needed in a minority of patients receiving conservative treatment, however, more frequently than in those receiving endovascular treatment.

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

Completed

Date of protocol fixation

2016

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Systematic review and meta-analysis of isolated spontaneous dissection of the superior mesenteric artery.

Registered date

2016

Year

09

Month

05

Day

Last modified on

2017

Year

08

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027548