UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008998 |
|---|---|
| Receipt number | R000010554 |
| Scientific Title | A prospective study of evaluating a safety of endoscopic ultrasound-guided fine needle aspiration in patients with antithrombotic agents |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2017/09/12 08:39:03 |
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Basic information
Public title
A prospective study of evaluating a safety of endoscopic ultrasound-guided fine needle aspiration in patients with antithrombotic agents
Acronym
A safety of EUS-FNA in patients with antithrombotic agents
Scientific Title
A prospective study of evaluating a safety of endoscopic ultrasound-guided fine needle aspiration in patients with antithrombotic agents
Scientific Title:Acronym
A safety of EUS-FNA in patients with antithrombotic agents
Region
| Japan |
Condition
Condition
Lesions with Indication for EUS-FNA
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a safety of EUS-FNA
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A rate of bleeding complication
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Age >20
2, Patients with high risk for thromboembolic event
1)within 2 months after coronary artery stent placement
2)within 12 months after coronary artery drug eluting stent placement
3)within 2 months after cerebral vascular surgery
4)cerebral infarction with stenosis in main artery more than 50%
5)Past history of cerebral infarction and transient ischemic attack
6)ASO with pain during rest
7)past history of cardiogenic cerebral infarction
8)atrial fibrilation with valvular disease
9)atrial fibrilation in patients with high risk for cerebral infarction
10)patients with mechanical heart mitral valve replacement
11)past history of cerebral infarction with mechanical heart valve replacement
12)antiphospholipid syndrome
13)deep venous thrombosis and pulmonary thromboembooism
3, written informed consent was obtained
Key exclusion criteria
1, PS 4
2, ASA >3
3, Pregnancy
4, contraindication for endoscopy
5, Platelate count < 50000/m3
6, PT-INR >2.0
7, EUS-FNA for cystic lesion
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawakami |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology
Zip code
Address
Kita14Nishi5, Kita-ku, Sapporo
TEL
0117161161
hiropon@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Nishioka |
Organization
Hokkaido University Hospital
Division name
IRB
Zip code
Address
Kita14 Nishi5, Kita-ku, Sapporo,Japan
TEL
011-706-7636
Homepage URL
midorin@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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
A multicenter prospective study in Hokkaido
Management information
Registered date
| 2012 | Year | 09 | Month | 28 | Day |
Last modified on
| 2017 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010554
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
