Central Compartment Neck Dissection With Thyroidectomy
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Purpose
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 | Intervention |
|---|---|
|
Indeterminate Thyroid Nodules |
Procedure: Total Thyroidectomy + CLND Procedure: Total thyroidectomy - CLND Procedure: Hemi-thyroidectomy + CLND Procedure: Hemi-thyroidectomy - CLND |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial |
- Short Term Hypo-calcemia [ Time Frame: < 1 month post-operatively ] [ Designated as safety issue: Yes ]Definition: Serum Ionized Calcium (ICa) < 0.9 mmol/L or symptoms related to hypocalcemia (acral or peri-oral paresthesia/numbess, tetany, muscle cramps/twitching, delirium etc.) and ICa < 1.0 mmol/L
- Long Term Hypocalcemia [ Time Frame: > 1month ] [ Designated as safety issue: Yes ]Definition: Serum Ionized Calcium (ICa) < 0.9 mmol/L or symptoms related to hypocalcemia (acral or peri-oral paresthesia/numbess, tetany, muscle cramps/twitching, delirium etc.) and ICa < 1.0 mmol/L
- Vocal Cord Dysfunction [ Time Frame: 1 month post-operatively ] [ Designated as safety issue: Yes ]
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 Hadicap Index)
- Positive Nodes [ Time Frame: At the time of operation. (Time 0) ] [ Designated as safety issue: No ]Presence of disease with in central lymph node dissection as per pathology report.
- Surgical Time [ Time Frame: During the operation. (Time 0) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Days spent in the hospital post-operatively.
| Estimated Enrollment: | 128 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jeffrey R Harris, MD, FRCSC | 780-407-8822 | jeffrey.harris@albertahealthservices.ca |
| Contact: Peter T Dziegielewski, MD | 780-407-8822 | ptd@ualberta.ca |
| Canada, Alberta | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G2B6 | |
| Contact: Jeffrey R Harris, MD, FRCSC 780-407-8822 jeffrey.harris@albertahealthservices.ca | |
| Contact: Peter T Dziegielewski, MD 780-407-8822 ptd@ualberta.ca | |
| Principal Investigator: Jeffrey R Harris, MD, FRCSC | |
| Sub-Investigator: Peter T Dziegielewski, MD | |
| Canada, Nova Scotia | |
| Dalhouise University | Not yet recruiting |
| Halifax, Nova Scotia, Canada, B3H3A7 | |
| Contact: Robert Hart, MD, FRCSC 902-473-2700 drrobhart@hotmail.com | |
| Contact: Elaine Fund, MD 902-473-2700 elaine.fung@dal.ca | |
| Sub-Investigator: Robert Hart, MD, FRCSC | |
| Sub-Investigator: Elaine Fung, MD | |
| 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 |
More Information
No publications provided
| Responsible Party: | Peter Dziegielewski, MD, FRCSC, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01106443 History of Changes |
| Other Study ID Numbers: | 88888 |
| Study First Received: | April 14, 2010 |
| Last Updated: | August 1, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Alberta:
|
Indeterminate thyroid nodule fine needle aspirate biopsy thyroidectomy central lymph node dissection |
Additional relevant MeSH terms:
|
Thyroid Nodule Thyroid Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Endocrine System Diseases Thyroid Diseases |
ClinicalTrials.gov processed this record on May 19, 2013