Central Compartment Neck Dissection With Thyroidectomy
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|ClinicalTrials.gov Identifier: NCT01106443|
Recruitment Status : Terminated (Poor patient accrual)
First Posted : April 19, 2010
Last Update Posted : December 14, 2016
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.
|Condition or disease||Intervention/treatment|
|Indeterminate Thyroid Nodules||Procedure: Total Thyroidectomy + CLND Procedure: Total thyroidectomy - CLND Procedure: Hemi-thyroidectomy + CLND Procedure: Hemi-thyroidectomy - CLND|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial|
|Study Start Date :||February 2010|
|Primary Completion Date :||July 2013|
|Study Completion Date :||October 2016|
Active Comparator: Total Thyroidectomy - CLND
Total thyroidectomy without central lymph node dissection.
Procedure: Total thyroidectomy - CLND
Removal of all possible thyroid tissue without dissection of neck level 6.
Experimental: Total Thyroidectomy +CLND
Total thyroidectomy with central lymph node dissection.
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.
Experimental: Hemi-thyroidectomy + CLND
Hemi-thyroidectomy with central lymph node dissection.
Procedure: Hemi-thyroidectomy + CLND
Removal of one thyroid lobe and ipsilateral central lymph nodes
Active Comparator: Hemi-thyroidectomy - CLND
Hemi-thyroidectomy without central lymph node dissection.
Procedure: Hemi-thyroidectomy - CLND
Removal of one thyroid lobe only. No lymphatic dissection.
- Short Term Hypo-calcemia [ Time Frame: < 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
- Long Term Hypocalcemia [ Time Frame: > 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 [ Time Frame: 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 [ Time Frame: At the time of operation. (Time 0) ]Presence of disease with in central lymph node dissection as per pathology report.
- Surgical Time [ Time Frame: 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 [ Time Frame: 1 day post-operatively on average ]Days spent in the hospital post-operatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106443
|University of Alberta|
|Edmonton, Alberta, Canada, T6G2B6|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H3A7|
|Study Director:||Peter T Dziegielewski, MD||University of Alberta|
|Principal Investigator:||Jeffrey R Harris, MD, FRCSC||University of Alberta|
|Study Chair:||Robert Hart, MD, FRCSC||Dalhousie University|
|Study Chair:||Elaine Fung, MD||Dalhousie University|