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Thyroid Nodule clinical trials

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NCT ID: NCT01292044 Completed - Thyroid Nodule Clinical Trials

The Role of Elastography in the Diagnosis of Thyroid Nodules

Start date: November 2011
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the role of elastography (along with echographic and cytological data) as a diagnostic tool for thyroid cancer

NCT ID: NCT01270425 Completed - Systemic Sclerosis Clinical Trials

Sonographic and Laboratory Evaluation of the Thyroid Gland in Patients With Systemic Sclerosis

Start date: January 2011
Phase: N/A
Study type: Observational

Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the skin, kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is prevalent in these patients and may be related to thyroid fibrosis or to thyroid autoimmune disease, i.e. hashimoto's thyroiditis. Thyroid nodules are prevalent in the general population, although some reports suggest they might be more frequent in patients with SSc. Hashimoto's thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid cancer. The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc with and without Hashimoto's disease

NCT ID: NCT01225016 Withdrawn - Thyroid Nodules Clinical Trials

Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

Start date: October 2010
Phase: N/A
Study type: Interventional

This study will evaluate thyroid nodules using specialized ultrasound imaging methods.

NCT ID: NCT01163565 Completed - Thyroid Nodule Clinical Trials

A Prospective Randomized Equivalence Trial to Evaluate the Safety of the Ligasure in Thyroid Surgery

Start date: April 2010
Phase: N/A
Study type: Interventional

This is a randomized, prospective equivalence trial on the safety of the Ligasure Vessel Sealing System as used in thyroid surgery. The Ligasure system is a hand held surgical device that uses heat to seal blood vessels during surgery. It has been a tested and accepted technology in abdominal surgery and it is now being applied to surgery of the thyroid gland because it is faster than the traditional method of tying blood vessels that a surgeon must do manually. To remove the thyroid gland safely the surgeon must dissect the gland away from the recurrent laryngeal nerve which controls the vocal cords and patient's voice. Protecting this nerve is the key step in all thyroid surgery as its damage can permanently alter a patient's voice and even obstruct the airway. At this time the worldwide accepted rate of nerve injury is 2 in 100 patients. The hypothesis of this study is that the nerve injury rates for surgery using the Ligasure device are similar to that seen when surgeons manually tie blood vessels. The investigators protocol will evaluate the function of the recurrent laryngeal nerve after removing the thyroid gland using the Ligasure device in comparison to the traditional method where the surgeon manually ties blood vessels. In this study, for patients undergoing total thyroidectomy for a benign condition, each patient will be randomized to have one lobe of thyroid (left or right) removed using manual tying of blood vessels and the other side will have the surgeon use the Ligasure device to seal blood vessels. Every patient has a pre− and post−operative independent assessment of vocal cord function using nasopharyngoscopy to ensure that the vocal cords are working normally prior to surgery and also to document vocal cord dysfunction if there is an injury to the recurrent laryngeal nerve. The investigators intent is to show that the Ligasure system is a safe method to sealing vessels in thyroid surgery and that the thermal dispersion of this device does not pose a significant increase in risk to the recurrent laryngeal nerve

NCT ID: NCT01106443 Terminated - Clinical trials for Indeterminate Thyroid Nodules

Central Compartment Neck Dissection With Thyroidectomy

Start date: February 2010
Phase: N/A
Study type: Interventional

When a patient presents with a thyroid mass, part of the work-up may include a fine needle aspiration biopsy (FNAB). The results of the biopsy then help plan treatment. If the results are benign, the management will typically be to follow the nodule. If the results demonstrate or are suspicious for cancer, such as papillary thyroid carcinoma (PTC), the treatment is a total thyroidectomy (total thyroid removal). The latest American thyroid association guidelines for PTC (2009) suggest that in many instances a central lymph node dissection (CLND) should be performed in conjunction with the total thyroidectomy. This procedure consists of removing the lymphatic (glandular) tissues surrounding the thyroid itself, as this tissue may have a propensity for cancer spread. The procedure's necessity has met much controversy in the last decade, but is becoming more of a standard in thyroid cancer surgery. When a thyroid nodule FNAB is reported as indeterminate, the treatment strategy is less clear cut. While a diagnostic hemi-thyroidectomy or therapeutic total thyroidectomy may be in order, the inclusion of CLND is not clearly defined. In many centers a CLND will be omitted with surgical management for an "indeterminate" lesion, while in others, it is standard protocol. The argument of performing CLND is largely based on the tenet that it adds little surgical time, cost or risks to the patient. Because the evidence of the prognostic role of lymph node metastases is limited many would argue that the risk of not performing CLND is greater than performing CLND. Furthermore, in the event of finding cancer on final pathology, and thus, having to re-operate in the thyroid/central compartment bed, post-operative complications may increase. Opponents of CLND argue that there is a paucity of strong evidence supporting CLND in the improvement of oncologic outcomes and can potentially increase post-operative low calcium levels or vocal nerve damage However, these recommendations are based on retrospective level III evidence. Thus the debate continues: is CLND justified as an adjunct to hemi-or total thyroidectomy in indeterminate thyroid pathology? The hypothesis is: CLND in hem- or total thyroidectomy for "indeterminate" thyroid nodules will not increase post-operative complications.

NCT ID: NCT01102127 Completed - Thyroid Cancer Clinical Trials

Elastography in Thyroid Nodules

Start date: February 2010
Phase: N/A
Study type: Observational

Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.

NCT ID: NCT00877630 Completed - Thyroid Nodule Clinical Trials

Minimal Invasiveness of Endoscopic Thyroidectomy

Start date: September 2006
Phase: N/A
Study type: Observational

The investigators had performed more than 250 cases of breast approach endoscopic thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally invasive procedure under the expert's hands.

NCT ID: NCT00858104 Completed - Thyroid Nodule Clinical Trials

Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

Start date: November 2008
Phase: Phase 4
Study type: Interventional

Thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. The majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term levothyroxine treatment has, however, several well-known side effects and limitations. During the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects. Aim of the study: 1. to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign thyroid nodules and on nodule-related symptoms, and to compare these effects with findings in control group without active therapy; 2. to assess the eventual re-occurence of thyroid lesions (observed after other types of ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up; 3. to demonstrate reproducibility of results within different environments and under different operators; 4. to validate eventual presence of major or minor side effects. To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up. Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.

NCT ID: NCT00651625 Completed - Cancer Clinical Trials

Reciprocating Medical Devices - a Study of a New Safety Device

RPD
Start date: November 2004
Phase: N/A
Study type: Interventional

The study design is a randomized study to directly compare the performance and the outcome of syringe and needle procedures with a standard syringe or the new reciprocating procedure device (RDP), which is a type of safety syringe. Over a 5 year period, 820 subjects who require and assent to a syringe and needle procedure for their usual and customary care will be randomized to either a conventional syringe or the RPD with one arm with and without ultrasound guidance. The RPD is designed to be safer, faster, less painful, and more effective for the patient, and the mechanics of the RPD are intended to provide the physician with better needle control, resulting in less needle trauma to patient tissues, and thus, reduced bleeding and pain for the patient. This clinical trial will address whether the RPD is indeed superior to the conventional syringe for shots, injections, and needle procedures, and whether it is a safer, less painful syringe.

NCT ID: NCT00615537 Completed - Thyroid Cancer Clinical Trials

Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

Start date: February 2008
Phase: N/A
Study type: Interventional

This proposal is designed as a pilot study for the use of laser ablation for local control of symptomatic (e.g compressive) benign thyroid masses in 20 patients.