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

Seung Bae Yoon

Status: Completed

Conditions: Pancreatic Neoplasms

Treatments: Device: EUS-FNB with 20 gauge ProCore needle; Device: EUS-FNB with 22 gauge ProCore needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02920944

EUS 20 gauge

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

EUS-FNB with 20-gauge

Experimental group

Description:

EUS-FNB with 20-gauge procore needle

Treatment:

Device: EUS-FNB with 20 gauge ProCore needle

EUS-FNB with 22-gauge

Active Comparator group

Description:

EUS-FNB with 22-gauge procore needle

Treatment:

Device: EUS-FNB with 22 gauge ProCore needle