Central Compartment Neck Dissection With Thyroidectomy

Summary

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.

Conditions

• Indeterminate Thyroid Nodules

Interventions

PROCEDURE

Total Thyroidectomy + CLND

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.

PROCEDURE

Total thyroidectomy - CLND

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

PROCEDURE

Hemi-thyroidectomy + CLND

Removal of one thyroid lobe and ipsilateral central lymph nodes

PROCEDURE

Hemi-thyroidectomy - CLND

Removal of one thyroid lobe only. No lymphatic dissection.

Sponsors & Collaborators

• University of Alberta

  lead OTHER

Principal Investigators

• Peter T Dziegielewski, MD · University of Alberta

• Jeffrey R Harris, MD, FRCSC · University of Alberta

• Robert Hart, MD, FRCSC · Dalhousie University

• Elaine Fung, MD · Dalhousie University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2013-07-31

Completion

2016-10-31

Countries

• Canada

Study Locations