UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023941 |
|---|---|
| Receipt number | 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 15:22:41 |
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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
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
yuuki-kitano@kitano-hp.or.jp
Sponsor or person
Institute
Cardiovascular Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027548
