UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of evaluating a safety of endoscopic ultrasound-guided fine needle aspiration in patients with antithrombotic agents
Title of the study (Brief title)	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	Hiroshi Kawakami
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology
Address	Kita14Nishi5, Kita-ku, Sapporo
TEL	0117161161
Email	hiropon@med.hokudai.ac.jp

Public contact
Name of contact person	Midori Nishioka
Organization	Hokkaido University Hospital
Division name	IRB
Address	Kita14 Nishi5, Kita-ku, Sapporo,Japan
TEL	011-706-7636
Homepage URL
Email	midorin@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 09 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010554