Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study

Overview

Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In this study we choose one, randomly, and fallow the result of cytologic evaluation regarding specimen adequacy.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2010

Detailed Description

Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24

Interventions

  • Procedure: FNA – fine needle aspiration
    • Fine Needle aspiration
  • Procedure: FNA – fine needle aspiration
    • Fine needle aspiration
  • Procedure: FNA – fine needle aspiration
    • Fine needle aspiration
  • Procedure: FNA – fine needle aspiration
    • Fine needle aspiration
  • Procedure: FNA – fine needle aspiration
    • Fine needle aspiration

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Needle 21 for FNA
  • Active Comparator: 2
    • 22 needle for FNA
  • Active Comparator: 3
    • 23 needle for FNA
  • Active Comparator: 4
    • 24 needle for FNA

Clinical Trial Outcome Measures

Primary Measures

  • specimen adequacy
    • Time Frame: 2 years

Secondary Measures

  • complication
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Any Woman with palpable Breast Mass Exclusion Criteria:

  • Previous open Biopsy or Surgery – Active infection – Breast cysts – Patient refusal to do FNA

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kashani Social Security Hospital
  • Provider of Information About this Clinical Study
    • Dr.Hamidzadeh, Kashani Social Security Hospital
  • Overall Official(s)
    • Bijan Mohammadhosseini, General Surgeon,MD, Principal Investigator, Kashani Social Security Hospital
  • Overall Contact(s)
    • Bijan — Mohammadhosseini, General Surgeon,MD, +989121009677, bijanmh@Gmail.com

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