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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023941
Receipt No. R000027548
Scientific Title Outcomes of Treatment Strategies for Isolated Spontaneous Superior Mesenteric Artery Dissection: A Systematic Review
Date of disclosure of the study information 2016/09/10
Last modified on 2017/08/06

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Basic information
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
Condition Isolated spontaneous superior mesenteric artery dissection
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes a composite of SMA dissection-related death and the use of an additional intervention (endovascular or surgery)
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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

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

Research contact person
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

Public contact
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

Sponsor
Institute Cardiovascular Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department

Funding Source
Organization Cardiovascular Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information Systematic review and meta-analysis of isolated spontaneous dissection of the superior mesenteric artery.

Management information
Registered date
2016 Year 09 Month 05 Day
Last modified on
2017 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027548

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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