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

Not Applicable
Completed
Conditions
Pancreatic Neoplasms
Interventions
Device: EUS-FNB with 22 gauge ProCore needle
Device: EUS-FNB with 20 gauge ProCore needle
Registration Number
NCT02920944
Lead Sponsor
Seung Bae Yoon
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 available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
35
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EUS-FNB with 22-gaugeEUS-FNB with 22 gauge ProCore needleEUS-FNB with 22-gauge procore needle
EUS-FNB with 20-gaugeEUS-FNB with 20 gauge ProCore needleEUS-FNB with 20-gauge procore needle
Primary Outcome Measures
NameTimeMethod
single diagnostic yield of the histologic coreup to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Secondary Outcome Measures
NameTimeMethod
total diagnostic yield of the histologic coreup to 5 minutes after endoscopic ultrasound-guided fine needle biopsy

Trial Locations

Locations (1)

The Catholic University of Korea

🇰🇷

Seoul, No State, Korea, Republic of

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