Gastrointestinal Tumors. Clinical Trial
Official title:
Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.
The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing
it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious
disorder.
This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently
approved by the U.S. Food and Drug Administration (FDA) for use.
Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G,
ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G,
Quick-Core, Cook Medical Inc., Winston-Salem, NC)
Secondary Objective To compare
- The number of needle passes requiring to acquire adequate specimen
- Length of core tissue obtained
- Diagnostic contribution of immunohistochemical staining
- Rates of complications
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic