Central Compartment Neck Dissection With Thyroidectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Alberta.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Peter Dziegielewski, University of Alberta
ClinicalTrials.gov Identifier:
NCT01106443
First received: April 14, 2010
Last updated: August 1, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106443

Contacts
Contact: Jeffrey R Harris, MD, FRCSC 780-407-8822 jeffrey.harris@albertahealthservices.ca
Contact: Peter T Dziegielewski, MD 780-407-8822 ptd@ualberta.ca

Locations
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         
Sponsors and Collaborators
University of Alberta
Dalhousie University
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

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

ClinicalTrials.gov processed this record on October 22, 2014