Central Compartment Neck Dissection With Thyroidectomy

Study Overview
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Brief Summary
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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.

Official Title
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Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial

Conditions
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Indeterminate Thyroid Nodules

Intervention / Treatment
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* Procedure: Total Thyroidectomy + CLND
* Procedure: Total thyroidectomy - CLND
* Procedure: Hemi-thyroidectomy + CLND
* Procedure: Hemi-thyroidectomy - CLND


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indeterminate or benign pathology on fine needle aspirate biopsy Scheduled to undergo total or hemi-thyroidectomy > 18 years old Exclusion Criteria: Previous thyroid surgery Previous neck surgery in field of thyroidectomy Previous neck irradiation Pre-operative hypocalcemia or hypoparathyroidism Biopsy suggestive of thyroid cancer Neck nodes suspicious for or with known cancer Pre-operative vocal cord dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Thyroidectomy - CLND<br>Total thyroidectomy without central lymph node dissection. | Procedure: Total thyroidectomy - CLND<br>* Removal of all possible thyroid tissue without dissection of neck level 6.<br>|
| Experimental: Total Thyroidectomy +CLND<br>Total thyroidectomy with central lymph node dissection. | Procedure: Total Thyroidectomy + CLND<br>* 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.<br>|
| Experimental: Hemi-thyroidectomy + CLND<br>Hemi-thyroidectomy with central lymph node dissection. | Procedure: Hemi-thyroidectomy + CLND<br>* Removal of one thyroid lobe and ipsilateral central lymph nodes<br>|
| Active Comparator: Hemi-thyroidectomy - CLND<br>Hemi-thyroidectomy without central lymph node dissection. | Procedure: Hemi-thyroidectomy - CLND<br>* Removal of one thyroid lobe only. No lymphatic dissection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Term Hypo-calcemia | 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 | < 1 month post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Hypocalcemia | 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 | > 1month | 
| Vocal Cord Dysfunction | 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) | 1 month post-operatively | 
| Positive Nodes | Presence of disease with in central lymph node dissection as per pathology report. | At the time of operation. (Time 0) | 
| Surgical Time | Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre. | During the operation. (Time 0) | 
| Length of Hospital Stay | Days spent in the hospital post-operatively. | 1 day post-operatively on average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indeterminate thyroid nodule, fine needle aspirate biopsy, thyroidectomy, central lymph node dissection