EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge

November 29, 2016 updated by: Kazumichi Kawakubo, Hokkaido Pancreatobiliary Endoscopic Intervention Study Group
To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Sapporo, Japan, 0608638
        • Recruiting
        • Hokkaido University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients taking anticoagulants who underwent EUS-FNA

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of bleeding adverse events
Time Frame: Within 2 weeks
Within 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of thromboembolic events
Time Frame: Within 2 weeks
Within 2 weeks
The rate of other adverse events
Time Frame: Within 2 weeks
Within 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hokkaido Pancreatobiliary Endoscopic Intervention Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 016-0040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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