Accepted Article

Article Type : 2 Original Article - Europe, excluding UK

Title New thyroid fine needle aspiration biopsy needle. Prospective, randomized, clinical study.

Authors Erhan Aysan MD Prof. Surgeon General, Bezmialem Vakif University Department of General Surgery Yeliz Ersoy MD Assoc. Prof. Surgeon General, Bezmialem Vakif University Department of General Surgery Zuhal Gucin MD Pathologist, Bezmialem Vakif University Department of General Surgery Merve Cengiz MD, General Surgery Resident, Bezmialem Vakif University Department of General Surgery Huseyin Akbulut General Surgery Resident, Bezmialem Vakif University Department of General Surgery Sema Arici MD Prof. Pathologist, Bezmialem Vakif University Department of General Surgery Mahmut Muslumanoglu MD Prof., Surgeon General, Bezmialem Vakif University Department of General Surgery

Location: Bezmialem Vakif University Department of General Surgery Bezmialem Vakif University Department of Pathology

Correspondence author (recipient of a research scholarship): Erhan Aysan Address: ATA-2 Sitesi Akasya Cad. No: 25 Cengelkoy, Uskudar Istanbul / TURKEY. Post code: 80700 e-mail: [email protected] Telephone: +90-216-4863059 Fax: +90-216-4863059

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/cen.12554 This article is protected by copyright. All rights reserved.

Accepted Article

Conflict of interest statement: We authors are warrants that, we have not taken any financial grant, material, products or any other contribition from any people or companies. We authors declerate that no any conflict of interest in this research.

Title New thyroid fine needle aspiration biopsy needle. Prospective, clinical study.

Introduction Nodular disease of thyroid in the adult population is common [1]. Estimated prevalence of thyroid nodules on the basis of palpation ranges from 3% to 7% [2]. During the past two decades, according to widespread use of ultrasonography (US) for evaluation of thyroid and nonthyroid neck diseases prevalence of clinically inapparent thyroid nodules is increased, estimated at 20% to 76% in the general population [3,4]. Although cosmesis and local compressive symptoms are the indications for thyroid surgery, most often cause of thyroidectomy is the risk of malignancy in the noduler diseases [5,6].

Because of the high prevalence of nodular thyroid disease, it is essential to develop and follow a reliable, cost-effective strategy for diagnosis and management [7]. Diagnosis and management of malign transformation of the nodules US guided fine needle aspiration biopsy (FNAB) remains the gold standard [8,9]. The possibility of selecting patients for prompt surgical treatment, low invasiveness, and relatively low cost of examination are the main advantages of FNAB [7,10-12]. Most important disadvantages of FNAB are different rates of inadequate (nondiagnostic) material aspiration and sensitivity [13-17].

To reduce inadequacy and increase sensitivity we designed, produced and patented a new FNAB needle. Before using it in a standart fashion percutaneusly under US guidiance we decided to design a preliminary research to evaluate effectiveness and potential complications intraoperatively. In this article we revealed the early results of this new FNAB needle.

Materials and Method Prelimany Study: Design, prototypes, producing the needle and patenting New FNAB needle is designed to consist of three basic parts (figure:1 and 2). Injector is a standart steril plastic aparat as frequently used in daily practice. Needle is like a standart steel

This article is protected by copyright. All rights reserved.

Accepted Article

medical injection needle, lower end is sharp-edged for minimal traumatic insertion through the tissues. Upper end has a ring compatable with the injector connection. Tissue blender part of the new FNAB is consisted of very thin and at least two steel wire tips which movable into the lumen of the needle. When the wire tips are brought close together, inserted through the lumen and pushed forward, the 5 mm wire tips come off the needle and expand in a 45° angle to provide more tissue for evaluation.

When the design is finalized, technical drawings were performed by an industrial engineer. Three different types of prototypes were produced by a medical products producing company (Dogan Medical® Co). After discussion meetings the product was decided to be produced that contained an injector of 22 gauge in 40 mm length, and a tissue blender with two steel wire tips (figüre 1 and 2). We qualified patent certification after six months applying to Turkish Patent Institude. (Title of invention: Biyopsi Aleti, Appl. Date: 05/27/2011, Appl. No: 2011/05207, Ref. No: P/5070-1).

Liminary Study Study was designed at Bezmialem Vakif University Faculty of Medicine, by the departments of general surgery and pathology as a prospective, randomized, controlled trial. The methodology was approved by the local ethics committee, registered to clinicalTrials.gov (NCT01512212) and informed consent was obtained from all patients. The subjects of this study were 120 patients with nodular goiter disease who admitted to Bezmialem Vakif University Faculty of Medicine, Endocrine Surgery Unit between March 2012 and October 2012 and got the indication of thyroidectomy. The sample number was calculated as 72 patients for 95% confidence level by GraphPad instat V.3 software in order to achieve 80% power. We randomly accepted patients (56 women, 16 men, women/men: 3.5, age range:2271 years , mean age: 47.5 years ) to the study according to thyroidectomy indications of our Endocrine Surgery Unit (Bethesda System for Reporting Thyroid Cytopathology atipy grade IV, V, VI with FNAB and/or >4cm nodule). Exclusion criteria were: age younger than 17 years, low grade than IV of Bethesda System grade and/or nodule diameter

New thyroid fine needle aspiration biopsy needle. Prospective, randomized, clinical study.

Nodular disease of thyroid in the adult population is common [1]. Estimated prevalence of thyroid nodules on the basis of palpation ranges from 3% to ...
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