search
Back to results

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

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EUS-FNB with 20 gauge ProCore needle
EUS-FNB with 22 gauge ProCore needle
Sponsored by
Seung Bae Yoon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Neoplasms

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Catholic University of Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EUS-FNB with 20-gauge

EUS-FNB with 22-gauge

Arm Description

EUS-FNB with 20-gauge procore needle

EUS-FNB with 22-gauge procore needle

Outcomes

Primary Outcome Measures

single diagnostic yield of the histologic core

Secondary Outcome Measures

total diagnostic yield of the histologic core

Full Information

First Posted
September 28, 2016
Last Updated
October 2, 2017
Sponsor
Seung Bae Yoon
Collaborators
Seoul St. Mary's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02920944
Brief Title
Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions
Official Title
Technical Feasibility and Diagnostic Yield of New 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions; Comparison With 22-gauge Procore Needle
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung Bae Yoon
Collaborators
Seoul St. Mary's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS-FNB with 20-gauge
Arm Type
Experimental
Arm Description
EUS-FNB with 20-gauge procore needle
Arm Title
EUS-FNB with 22-gauge
Arm Type
Active Comparator
Arm Description
EUS-FNB with 22-gauge procore needle
Intervention Type
Device
Intervention Name(s)
EUS-FNB with 20 gauge ProCore needle
Intervention Description
EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
Intervention Type
Device
Intervention Name(s)
EUS-FNB with 22 gauge ProCore needle
Intervention Description
EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
Primary Outcome Measure Information:
Title
single diagnostic yield of the histologic core
Time Frame
up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Secondary Outcome Measure Information:
Title
total diagnostic yield of the histologic core
Time Frame
up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Seok Lee, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Director
Facility Information:
Facility Name
The Catholic University of Korea
City
Seoul
State/Province
No State
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs