Central Compartment Neck Dissection With Thyroidectomy

NCT01106443 | Terminated

• 1 other identifier: 88888
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Indeterminate Thyroid Nodules

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Long Term Hypocalcemia

  > 1month

• Vocal Cord Dysfunction

  1 month post-operatively

• Positive Nodes

  At the time of operation. (Time 0)

• Surgical Time

  During the operation. (Time 0)

• Length of Hospital Stay

  1 day post-operatively on average

Study Arms (4)

Total Thyroidectomy - CLND

ACTIVE COMPARATOR

Total thyroidectomy without central lymph node dissection.

Procedure: Total thyroidectomy - CLND

Total Thyroidectomy +CLND

EXPERIMENTAL

Total thyroidectomy with central lymph node dissection.

Procedure: Total Thyroidectomy + CLND

Hemi-thyroidectomy + CLND

EXPERIMENTAL

Hemi-thyroidectomy with central lymph node dissection.

Procedure: Hemi-thyroidectomy + CLND

Hemi-thyroidectomy - CLND

ACTIVE COMPARATOR

Hemi-thyroidectomy without central lymph node dissection.

Procedure: Hemi-thyroidectomy - CLND

Interventions

Total thyroidectomy - CLND PROCEDURE

Removal of all possible thyroid tissue without dissection of neck level 6.

Total Thyroidectomy - CLND

Hemi-thyroidectomy - CLND PROCEDURE

Removal of one thyroid lobe only. No lymphatic dissection.

Hemi-thyroidectomy - CLND

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indeterminate or benign pathology on fine needle aspirate biopsy
• Scheduled to undergo total or hemi-thyroidectomy
• \> 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G2B6, Canada

Location

Dalhouise University

Halifax, Nova Scotia, B3H3A7, Canada

Location

Study Officials

• Peter T Dziegielewski, MD

  University of Alberta

  STUDY DIRECTOR

• Jeffrey R Harris, MD, FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Robert Hart, MD, FRCSC

  Dalhousie University

  STUDY CHAIR

• Elaine Fung, MD

  Dalhousie University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 19, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2016
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

CA (2)