Central Compartment Neck Dissection With Thyroidectomy

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.

Study Overview

• Status: Terminated
• Conditions: Indeterminate Thyroid Nodules
• Intervention / Treatment: Procedure: Total thyroidectomy - CLND; Procedure: Total Thyroidectomy + CLND; Procedure: Hemi-thyroidectomy + CLND; Procedure: Hemi-thyroidectomy - CLND

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G2B6
      • University of Alberta
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H3A7
      • Dalhouise University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Term Hypo-calcemia	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	< 1 month post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Hypocalcemia	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	> 1month
Vocal Cord Dysfunction	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)	1 month post-operatively
Positive Nodes	Presence of disease with in central lymph node dissection as per pathology report.	At the time of operation. (Time 0)
Surgical Time	Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre.	During the operation. (Time 0)
Length of Hospital Stay	Days spent in the hospital post-operatively.	1 day post-operatively on average

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 14, 2010
• First Submitted That Met QC Criteria: April 16, 2010
• First Posted (Estimate): April 19, 2010

Study Record Updates

• Last Update Posted (Estimate): December 14, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Indeterminate thyroid nodule; thyroidectomy; fine needle aspirate biopsy; central lymph node dissection
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: 88888