Clinical trial NCT01106443: Central Compartment Neck Dissection With Thyroidectomy
Official title: Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Indeterminate Thyroid Nodules
Keywords: Indeterminate thyroid nodule
fine needle aspirate biopsy
thyroidectomy
central lymph node dissection
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Short Term Hypo-calcemia
timeFrame: < 1 month post-operatively
Secondary outcomes:
measure: Long Term Hypocalcemia
timeFrame: > 1month
measure: Vocal Cord Dysfunction
timeFrame: 1 month post-operatively
measure: Positive Nodes
timeFrame: At the time of operation. (Time 0)
measure: Surgical Time
timeFrame: During the operation. (Time 0)
measure: Length of Hospital Stay
timeFrame: 1 day post-operatively on average
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Halifax
country: Canada
facility: Dalhouise University
state: Nova Scotia
Study officials:
affiliation: University of Alberta
name: Peter T Dziegielewski, MD
role: STUDY_DIRECTOR
affiliation: University of Alberta
name: Jeffrey R Harris, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Robert Hart, MD, FRCSC
role: STUDY_CHAIR
affiliation: Dalhousie University
name: Elaine Fung, MD
role: STUDY_CHAIR
References: