Central Compartment Neck Dissection With Thyroidectomy
Conditions
Indeterminate Thyroid Nodules
Conditions: official terms
Thyroid Nodule
Conditions: Keywords
Indeterminate thyroid nodule, fine needle aspirate biopsy, thyroidectomy, central lymph node dissection
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Total Thyroidectomy + CLND Type: Procedure
Name: Total thyroidectomy - CLND Type: Procedure
Name: Hemi-thyroidectomy + CLND Type: Procedure
Name: Hemi-thyroidectomy - CLND Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
University of Alberta
Edmonton, Alberta, Canada
Status: Recruiting
Contact: Jeffrey R Harris, MD, FRCSC - 780-407-8822 - jeffrey.harris@albertahealthservices.ca
Dalhouise University
Halifax, Nova Scotia, Canada
Status: Not yet recruiting
Contact: Robert Hart, MD, FRCSC - 902-473-2700 - drrobhart@hotmail.com
Start Date
February 2010
Completion Date
December 2013
Sponsors
University of Alberta
Source
University of Alberta
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page