EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge

Endoscopic Ultrasonography-guided Fine Needle Aspiration Clinical Trial

Official title:

EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977650
• Other study ID #: 016-0040
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2016
• Last updated: November 29, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: Hokkaido Pancreatobiliary Endoscopic Intervention Study Group
• Contact: Kazumichi Kawakubo, Ph.D.
• Phone: 117161161
• Email: kkawakubo-gi[@]umin.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Taking anticoagulants

• Written informed consent

Exclusion Criteria:

• Platelets count less than 50000/µl

• PT-INR more than 2.6

• ASA more than 3

• Severe bleeding tendency

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endoscopic Ultrasonography-guided Fine Needle Aspiration

Intervention

Procedure:
• Endoscopic ultrasonography-guided fine needle aspiration

Locations

Country	Name	City	State
Japan	Hokkaido University Hospital	Sapporo

Sponsors (1)

Lead Sponsor	Collaborator
Hokkaido Pancreatobiliary Endoscopic Intervention Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of bleeding adverse events		Within 2 weeks	Yes
Secondary	The rate of thromboembolic events		Within 2 weeks	Yes
Secondary	The rate of other adverse events		Within 2 weeks	Yes