Central Compartment Neck Dissection With Thyroidectomy

• ClinicalTrials.gov Identifier: NCT01106443
• Recruitment Status: Terminated
• First Posted: April 19, 2010
• Last Update Posted: December 14, 2016
• Sponsor: University of Alberta
• Information provided by (Responsible Party): Peter Dziegielewski, University of Alberta

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Indeterminate Thyroid Nodules	Procedure: Total Thyroidectomy + CLND; Procedure: Total thyroidectomy - CLND; Procedure: Hemi-thyroidectomy + CLND; Procedure: Hemi-thyroidectomy - CLND	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial
• Study Start Date: February 2010
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: October 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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)

3. Positive Nodes [ Time Frame: At the time of operation. (Time 0) ]
   Presence of disease with in central lymph node dissection as per pathology report.
4. 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.
5. Length of Hospital Stay [ Time Frame: 1 day post-operatively on average ]
   Days spent in the hospital post-operatively.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Alberta

University of Alberta

Edmonton, Alberta, Canada, T6G2B6

Canada, Nova Scotia

Dalhouise University

Halifax, Nova Scotia, Canada, B3H3A7

Sponsors and Collaborators

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

More Information

• Responsible Party: Peter Dziegielewski, MD, FRCSC, University of Alberta
• ClinicalTrials.gov Identifier: NCT01106443
• Other Study ID Numbers: 88888
• First Posted: April 19, 2010
• Last Update Posted: December 14, 2016
• Last Verified: December 2016

Keywords provided by Peter Dziegielewski, University of Alberta:

Indeterminate thyroid nodule; fine needle aspirate biopsy; thyroidectomy; central lymph node dissection

Additional relevant MeSH terms:

Thyroid Nodule; Thyroid Diseases; Endocrine System Diseases; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms