NCT02977650

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

Same day

First QC Date

November 28, 2016

Last Update Submit

November 29, 2016

Conditions

Endoscopic Ultrasonography-guided Fine Needle Aspiration

Outcome Measures

Primary Outcomes (1)

  • The rate of bleeding adverse events

    Within 2 weeks

Secondary Outcomes (2)

  • The rate of thromboembolic events

    Within 2 weeks

  • The rate of other adverse events

    Within 2 weeks

Interventions

Endoscopic ultrasonography-guided fine needle aspirationPROCEDURE
Also known as: EUS-FNA

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients taking anticoagulants who underwent EUS-FNA

You may qualify if:

  • Taking anticoagulants
  • Written informed consent

You may not qualify if:

  • Platelets count less than 50000/μl
  • PT-INR more than 2.6
  • ASA more than 3
  • Severe bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hokkaido University Hospital

Sapporo, 0608638, Japan

RECRUITING

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Central Study Contacts

Kazumichi Kawakubo, Ph.D.

CONTACT

117161161kkawakubo-gi@umin.ac.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations

JP(1)