Central Compartment Neck Dissection With Thyroidectomy
- Conditions
- Indeterminate Thyroid Nodules
- Interventions
- Procedure: Hemi-thyroidectomy + CLNDProcedure: Total thyroidectomy - CLNDProcedure: Total Thyroidectomy + CLNDProcedure: Hemi-thyroidectomy - CLND
- Registration Number
- NCT01106443
- Lead Sponsor
- University of Alberta
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 128
- Indeterminate or benign pathology on fine needle aspirate biopsy
- Scheduled to undergo total or hemi-thyroidectomy
- > 18 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hemi-thyroidectomy + CLND Hemi-thyroidectomy + CLND Hemi-thyroidectomy with central lymph node dissection. Total Thyroidectomy - CLND Total thyroidectomy - CLND Total thyroidectomy without central lymph node dissection. Total Thyroidectomy +CLND Total Thyroidectomy + CLND Total thyroidectomy with central lymph node dissection. Hemi-thyroidectomy - CLND Hemi-thyroidectomy - CLND Hemi-thyroidectomy without central lymph node dissection.
- Primary Outcome Measures
Name Time Method Short Term Hypo-calcemia < 1 month post-operatively 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
- Secondary Outcome Measures
Name Time Method Long Term Hypocalcemia > 1month 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
Vocal Cord Dysfunction 1 month post-operatively 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)Positive Nodes At the time of operation. (Time 0) Presence of disease with in central lymph node dissection as per pathology report.
Surgical Time During the operation. (Time 0) Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre.
Length of Hospital Stay 1 day post-operatively on average Days spent in the hospital post-operatively.
Trial Locations
- Locations (2)
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Dalhouise University
🇨🇦Halifax, Nova Scotia, Canada