Indeterminate Thyroid Nodules Clinical Trial
Official title:
Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05851404 -
Management of Indeterminate Thyroid Nodules Across Different World Regions
|