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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02920944

Enrollment

Registered

2016-09-30

Start date

2016-07-31

Completion date

2017-10-31

Last updated

2017-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

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.

Interventions

DEVICEEUS-FNB with 20 gauge ProCore needle

EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

DEVICEEUS-FNB with 22 gauge ProCore needle

EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026