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Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.


N/A
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Tumors.

Thank you

Trial Information

Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.


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

Inclusion Criteria


Inclusion criteria:

- Solid tumors ≥ 2 cm in size.

Exclusion criteria:

- Thrombocytopenia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

The size of core biopsy obtained by the ProCore and QuickCore biopsy needles. Larger core iopsy specimen-yield.

Outcome Description:

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)

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

John M. DeWitt, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121

Authority:

United States: Institutional Review Board

Study ID:

1104-03

NCT ID:

NCT01768325

Start Date:

January 2012

Completion Date:

January 2013

Related Keywords:

  • Gastrointestinal Tumors.
  • ProCore Needle
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms

Name

Location

Indiana University HospitalIndianapolis, Indiana  46202