Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Total thyroidectomy without central lymph node dissection.

Total thyroidectomy with central lymph node dissection.

Hemi-thyroidectomy with central lymph node dissection.

Hemi-thyroidectomy without central lymph node dissection.

Total thyroidectomy includes removing all possible thyroid tissue. Central lymph node dissection is a neck level 6 dissection. This includes removal of all central lymphatics from carotid artery to carotid artery and hyoid to sternum/clavicle.

Total Thyroidectomy + CLND

Removal of all possible thyroid tissue without dissection of neck level 6.

Total thyroidectomy - CLND

Removal of one thyroid lobe and ipsilateral central lymph nodes

Hemi-thyroidectomy + CLND

Removal of one thyroid lobe only. No lymphatic dissection.

Hemi-thyroidectomy - CLND

Peter T Dziegielewski, MD

Jeffrey R Harris, MD, FRCSC

Robert Hart, MD, FRCSC

Elaine Fung, MD

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.

Central Compartment Neck Dissection With Thyroidectomy

Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial

Definition: Serum Ionized Calcium (ICa) \< 0.9 mmol/L or symptoms related to hypocalcemia (acral or peri-oral paresthesia/numbness, tetany, muscle cramps/twitching, delirium etc.) and ICa \< 1.0 mmol/L

A surrogate for recurrent laryngeal nerve function. Determined pre- and post-operatively via flexible naso-pharyngoscopy (standard of care).

- evaluated by a validated measure (Voice Handicap Index)

Presence of disease with in central lymph node dissection as per pathology report.

Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre.

Days spent in the hospital post-operatively.

University of Alberta

MD, FRCSC

Carcinoma

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR

Thyroidectomy

Fabio Medas, MD

Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Fine needle aspiration cytology (FNAC) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. Nevertheless, FNAC is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class III and class IV according to Bethesda Classification\[2\]). In fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. Thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems.

We aim to evaluate different approaches to indeterminate nodules across different countries in the world.

Management of Indeterminate Thyroid Nodules Across Different World Regions

Management of Indeterminate Thyroid Nodules Across Different World Regions: a Multicentric International Study

Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules

Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules

University of Cagliari

Associate Professor

Patients with indeterminate thyroid nodule and pathological diagnosis of thyroid carcinoma

Patients with indeterminate thyroid nodule and pathological diagnosis of follicular adenoma

The following items will be evaluated:

* cell free dna length and integrity
* presence or absence of SNPs in cfDNA and in DNA extracted from surgical samples
* qualitative and quantitative evaluation of serum and surgical specimens proteome (proteomics)

Multiomic analyses of blood and surgical specimens

Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules.

Assessment the Cancer Risk of Indeterminate Thyroid Nodules Through Integration of Clinical, Ultrasonographic and Multiomic Features

A Novel, Multimodal, Machine-learning Grounded Approach to Assess the Oncological Risk of Indeterminate Thyroid Nodules

Individual participant data will be available under reasonable request

Identification of alterations in cfDNA length and integrity, presence of SNPs in cfDNA, alterations of serum proteome predictive of thyroid carcinoma

Elanoration of diagnostic algorithm predictive of thyroid carcinoma through integration of clinical, ultrasonographic and multiomic variables able to predict che condition of thyroid cancer in patients with indeterminate thryoid nodules

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Central Compartment Neck Dissection With Thyroidectomy	NCT01106443	Indeterminate T...	Total Thyroidec... Total thyroidec... Hemi-thyroidect... Hemi-thyroidect...	18 Years -	University of Alberta
Management of Indeterminate Thyroid Nodules Across Different World Regions	NCT05851404	Indeterminate T...	Thyroidectomy	-	University of Cagliari
Central Compartment Neck Dissection With Thyroidectomy	NCT01106443	Indeterminate T...	Total Thyroidec... Total thyroidec... Hemi-thyroidect... Hemi-thyroidect...	18 Years -	University of Alberta
Management of Indeterminate Thyroid Nodules Across Different World Regions	NCT05851404	Indeterminate T...	Thyroidectomy	-	University of Cagliari
Assessment the Cancer Risk of Indeterminate Thyroid Nodules Through Integration of Clinical, Ultrasonographic and Multiomic Features	NCT05428371	Thyroid Nodule Thyroid Cancer	Multiomic analy...	18 Years -	University of Cagliari
Management of Indeterminate Thyroid Nodules Across Different World Regions	NCT05851404	Indeterminate T...	Thyroidectomy	-	University of Cagliari

Spots Global Cancer Trial Database for indeterminate thyroid nodule