Diagnostic Yield of 20-gauge Procore Needle for EUS-guide... | NCT02920944

Studies
Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions

NCT02920944

Sponsor

Seung Bae Yoon

Status

Completed

Last Update Posted

Oct 3, 2017Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Pancreatic Neoplasms

Interventions

EUS-FNB with 20 gauge ProCore needle
EUS-FNB with 22 gauge ProCore needle

Countries

South Korea

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Sep 28, 2016

First Submission Date that Met QC Criteria

Sep 28, 2016

First Posted Date

Sep 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

Oct 2, 2017

Last Update Posted Date

Oct 3, 2017Actual

Name	Class
Seoul St. Mary's Hospital	OTHER

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

Description Module

Brief Summary

This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUS-FNB with 20-gauge	Experimental	EUS-FNB with 20-gauge procore needle	Device: EUS-FNB with 20 gauge ProCore needle
EUS-FNB with 22-gauge	Active Comparator	EUS-FNB with 22-gauge procore needle	Device: EUS-FNB with 22 gauge ProCore needle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUS-FNB with 20 gauge ProCore needle	Device	EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)	EUS-FNB with 20-gauge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
single diagnostic yield of the histologic core		up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy

Secondary Outcomes

Measure	Description	Time Frame
total diagnostic yield of the histologic core		up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.

Exclusion Criteria:

cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
In Seok Lee, MD	The Catholic University of Korea	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Catholic University of Korea		Seoul	No State	06591	South Korea

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

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided