Central Compartment Neck Dissection With Thyroidectomy

Indeterminate Thyroid Nodules Clinical Trial

Official title:

Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01106443
• Other study ID #: 88888
• Status: Terminated
• Phase: N/A
• First received: April 14, 2010
• Last updated: December 13, 2016
• Start date: February 2010
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 128
• Est. completion date: October 2016
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Indeterminate Thyroid Nodules
• Thyroid Nodule

Intervention

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.
• Total thyroidectomy - CLND
Removal of all possible thyroid tissue without dissection of neck level 6.
• Hemi-thyroidectomy + CLND
Removal of one thyroid lobe and ipsilateral central lymph nodes
• Hemi-thyroidectomy - CLND
Removal of one thyroid lobe only. No lymphatic dissection.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Dalhouise University	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Positive Nodes	Presence of disease with in central lymph node dissection as per pathology report.	At the time of operation. (Time 0)	No
Secondary	Surgical Time	Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre.	During the operation. (Time 0)	No
Secondary	Length of Hospital Stay	Days spent in the hospital post-operatively.	1 day post-operatively on average	No