EUS-FNA for Patients Taking Anticoagulants Without Hepari... | NCT02977650

Studies
EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge

NCT02977650

Sponsor

Hokkaido Pancreatobiliary Endoscopic Intervention Study Group

Status

Unknown status

Last Update Posted

Nov 30, 2016Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Endoscopic Ultrasonography-guided Fine Needle Aspiration

Interventions

Endoscopic ultrasonography-guided fine needle aspiration

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Nov 2016Actual

Completion Date

Not provided

First Submitted Date

Nov 28, 2016

First Submission Date that Met QC Criteria

Nov 29, 2016

First Posted Date

Nov 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2016

Last Update Posted Date

Nov 30, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kazumichi Kawakubo, M.D., Ph.D., Hokkaido Pancreatobiliary Endoscopic Intervention Study GroupPrincipal Investigator

Lead Sponsor

Hokkaido Pancreatobiliary Endoscopic Intervention Study GroupNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic ultrasonography-guided fine needle aspiration	Procedure			EUS-FNA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients taking anticoagulants who underwent EUS-FNA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kazumichi Kawakubo, Ph.D.	Contact	117161161		kkawakubo-gi@umin.ac.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hokkaido University Hospital	Recruiting	Sapporo		0608638	Japan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061765	Endoscopic Ultrasound-Guided Fine Needle Aspiration

Ancestor Terms

ID	Term
D044963	Biopsy, Fine-Needle
D001707	Biopsy, Needle
D001706	Biopsy
D003581	Cytodiagnosis

Browse Leaves

Not provided

Browse Branches

Not provided