UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Outcomes of Treatment Strategies for Isolated Spontaneous Superior Mesenteric Artery Dissection: A Systematic Review
Title of the study (Brief title)	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	Takao Kato
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
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	Yuki Kimura
Organization	Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name	Cardiovascular Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.annalsofvascularsurgery.com/article/S0890-5096(17)30917-2/fulltext
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.
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